2020 - The materials on this website are for your general educational information only. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. If so, do not buy this item unless you are an authorized purchaser. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. We do not practice medicine or provide medical services or advice as a part of this website. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. The NuVasive TLIF philosophy, coupled with its comprehensive portfolio, provides open and MAS procedural systems that include the requisite tools surgeons need to plan surgery, access affected levels, restore alignment and disc height, provide optimized fixation, and deliver graft material. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Our Standards: The Thomson Reuters Trust Principles. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). $1,299.99. hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. Headquarters United States of America. Price: $5.00 per kit. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. 789 0 obj <> endobj For the best experience on our site, be sure to turn on Javascript in your browser. 'VUJ)(h. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; NUVASIVE: 2012022 SKU# 2012022-WE1. Malone, H., Mundis, G. M., Jr., Collier, M, et al. Read the press release Clinical benefits ALIF Anterior approaches, such as in ALIF, allow access to the discs at the front of the spine and do not require muscle stripping as in posterior approaches. That no more than two devices should be implanted at a time. For the best experience on our site, be sure to turn on Javascript in your browser. Expected delivery: 3 weeks. The Sage Lateral Plate System See here for a complete list of exchanges and delays. NUVASIVE: 2012022 - WestCMR Photos are for illustration purposes only and may not depict the exact item. Polini A, Pisignano D, Parodi M, et al. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. 2.0 Scope PDF NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs System Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients. 2. One position. Robert Eastlack and Gregory Mundis. %PDF-1.4 % Thu, October 4th, 2018. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. 1. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f At NuVasive, we transform surgery, advanced care, and change lives. The Simplify Disc is supported by level-1 evidence through the FDA investigational device exemption (IDE) study1 and was found to be clinically superior to ACDF in the randomized controlled trial. or more while undergoing treatment, and. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible Before sharing sensitive information, make sure you're on a federal government site. PDF Document Title: Visual and Cosmetic Standards for Manufacturing hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl Prices excluding VAT and shipping. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. Reline 3D, which is an extension to the NuVasive's Reline system, is part of the firm's comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. Disc space preparation 5. About NuVasive All quotes delayed a minimum of 15 minutes. Eastlack and Mundis as they discuss, Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?, recently published in the Journal of Neurosurgery Spine. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. List of devices made by the manufacturer NUVASIVE, INC. function gtag(){dataLayer.push(arguments);} The .gov means its official.Federal government websites often end in .gov or .mil. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to . var site_url = "https://www.medicaldevices24.com/"; This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to help transform spine surgery, and ultimately change the lives of your patients. Spine 2020;45(14):944-51. Height 25cm, diameter 7cm - Volume: 500 ml. Simplify Medical is located in Sunnyvale, California. Biomater Sci 2018;6:136-45. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. 1Simplify Cervical Artificial Disc P200022. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Open the catalog to page 2 What is causing my pain? Product images are for display only. All rights reserved. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. 50 - 99 pieces - 8,75. NuVasive is the fastest growing, full-line spine company. NuVasive is the fastest growing, full-line spine company. Expected delivery: 2 weeks. Retroperitoneal access 3. Investor Conference Call 1997-2023 WestCMR. NV Dynamic Stimulation Clip and Inline Activator. Quantity: All Trademarks & Logos belong to their respective owners. Peer-to-peer discussion between Drs. See here for a complete list of exchanges and delays. iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. This power bank is suitable for charging any device. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. PDF NuVasive, Incorporated March 25, 2020 - Food and Drug Administration NuVasive is developing the operating room of the future. Prices excluding VAT and shipping. Sign in to add this product to your favorites! N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! All products | NuVasive Webshop NuVasive is developing the operating room of the future. This is why we show up every day, united and committed to our vision. You have not been assigned a username and password. *Data on file. For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. Alignment Matters . Do not implant in patients under 18 years of age. Based on review of publicly available materials at the time of this release. The site is secure. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream Login - NuVasive Company Store - Direct EDJE UPDATE: Potential Concerns with NuVasive Precice Devices Make sure cookies are enabled in your browser. In an effort to evolve the standard of care for early-onset scoliosis (EOS) and adolescent deformity patients, we have invested in a comprehensive product portfolio that introduces surgical efficiencies and optimized implant constructs, and we remain committed to supporting the progression of clinical education and scientific research in this space. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. multi-level pathologies. Lehr MA, Oner CF, Delawi D, et al. The potential combination would accelerate consolidation in the spine surgery market, where smaller players are turning to dealmaking to compete against the likes of Johnson & Johnson (JNJ.N), Medtronic Plc (MDT.N) and Zimmer Biomet Holdings Inc (ZBH.N). NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. Excluding VAT and shipping. 3. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. $5,499.99. NuVasive provides patient support and surgeon education. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. An official website of the United States government, : Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. Excluding VAT and shipping. Globus Medical eyes acquisition of spinal implant maker NuVasive These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. NuVasive introduces new Reline 3D posterior fixation system Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. Excluding VAT and shipping. Expected delivery: 3 weeks. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. You should always talk to your healthcare professional for diagnosis and treatment. 2Data on file. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. Home | NuVasive NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasives results to differ materially from historical results or those expressed or implied by such forward-looking statements. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. NuVasive Company Profile - Office Locations, Competitors, Revenue ALIF - NuVasive Journal of Neurosurgery Spine. Unhappy? Product Code: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130). Osteocel is human tissue donated specifically for human clinical use. Get your money back!. NuVasive offers solutions to alleviate patient symptoms. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. NuVasive Acquires Simplify Medical - NuVasive The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. COMPANY CONFIDENTIAL. PDF San Diego, CA 92121 PCM - Food and Drug Administration nuvasive product catalog pdf The industry leader for online information for tax, accounting and finance professionals. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. Learn how intelligent surgery can change your practice. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. Becoming the number one partner in pediatrics. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. You don't have to face this journey alone. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . Copyright 2022 Oisto. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said. var base_url = "https://www.medicaldevices24.com/"; Telephone 1 858 9091800. %PDF-1.5 % Duan R, Barbieri D, Luo X, et al. WestCMR does not provide advice, training, or clinical support. 5. NuVasive is developing the operating room of the future. List of devices made by the manufacturer NUVASIVE, INC. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. It will also discuss the Simplify Medical transaction at that time. Tell us something about it and help others to make the right decision, We use UPS, Fedex, USPS and our sellers ship quickly and securely, Customer satisfaction is our top priority, we are not happy until you are happy. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. Excluding VAT and shipping. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. Surgical efficiency. Expected delivery: 3 weeks. The store will not work correctly in the case when cookies are disabled. Expected delivery: 3 weeks. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. Neurocare Products. As of date of publication, March 2017; data on file. NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for Propel DBM Fibers and Propel DBM Sponge are 100% bone and are intended for homologous use in the repair, replacement, or reconstruction of skeletal defects. (Top row): NuVasive DBM putty and gel and NuVasive amniotic membrane DS (Bottom Row): Traditional bone allograft and DBM fibers / Courtesy of NuVasive, Inc. NuVasive, Inc. has announced U.S. commercial launch of three new biologics . Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. Reimagine cervical spine surgery. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. The subject Website www.nuvasive.com. The Companys comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders..
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