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. NuVasive Inc Company Profile - GlobalData nuvasive product catalog pdf Price: $5.00 per kit. 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). 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. 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. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. *Data on file. gtag('js', new Date()); NV Dynamic Stimulation Clip and Inline Activator. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. xZrJ]e7,[Uv%d|7@$$! The three essential biologic mechanisms involved in complete bone grafts include osteoconduction (a scaffold for the reparative growth of the natural bone), osteoinduction (signals encouraging undifferentiated cells to become active osteoblasts), and osteogenesis (living bone cells in the graft material contribute to bone remodeling). As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. 4. Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients. At NuVasive, we aspire to change a patients life every minute. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. Appropriate patient positioning 2. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. Do not implant in patients under 18 years of age. If so, do not buy this item unless you are an authorized purchaser. Expected delivery: 2 weeks. The store will not work correctly in the case when cookies are disabled. Get your money back!. PDF eXtreme - SMISS For the best experience on our site, be sure to turn on Javascript in your browser. 50 - 99 pieces - 8,75. An official website of the United States government, : 1 Terran J, Schwab F, Shaffrey CI, et al. Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. 5. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. CODE: NS10000565. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. SAN DIEGO February 24, 2021 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR). The materials on this website are for your general educational information only. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. 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. Quantity: As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. You should always talk to your healthcare professional for diagnosis and treatment. combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Spine 2020;45(14):944-51. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. Polini A, Pisignano D, Parodi M, et al. All Trademarks referred to are the property of their respective owners. One position. 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). The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. UPDATE: Potential Concerns with NuVasive Precice Devices Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. ALIF - NuVasive PLoS ONE 2011;6(10):1-8. Expected delivery: 3 weeks. 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. 1.0 Purpose. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. 1Simplify Cervical Artificial Disc P200022. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. Becoming the number one partner in pediatrics. List of devices made by the manufacturer NUVASIVE, INC. Adhering to the three core principles of Advanced Materials ScienceSurface, Structure, and ImagingNuVasive has pioneered design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of PEEK and titanium to create implants intelligently designed for fusion. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Osteocel is human tissue donated specifically for human clinical use. All rights reserved. Prices excluding VAT and shipping. December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics' Precice devices made from. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! 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. Our Standards: The Thomson Reuters Trust Principles. At NuVasive, we transform surgery, advanced care, and change lives. The materials on this website are for your general educational information only. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. 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.
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