WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. Biologics - NuVasive Simplify Medical is located in Sunnyvale, California. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. 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. Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. PDF eXtreme - SMISS Implant insertion NuVasive funded the upfront payment at closing using available cash on hand. Peer-to-peer discussion between Drs. Learn more about the value of Biologics Information you need When fusion is recommended Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. NuVasive introduces new Reline 3D posterior fixation system 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 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. NuVasive is developing the operating room of the future. 5. You should always talk to your healthcare professional for diagnosis and treatment. If the item is subject to FDA regulation, seller must verify your status as an authorized purchaser of this item before shipping of the item. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. Intelligently designed for fusion. All products sold by WestCMR are in-date. The X360 System is a comprehensive approach to lateral single-position surgery powered by Surgical Intelligence, an ecosystem of technologies enabling safer, faster, smarter surgery. %%EOF The site is secure. Learn how intelligent surgery can change your practice. 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. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? NuVasive is developing the operating room of the future. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. Retroperitoneal access 3. Transaction Details The materials on this website are for your general educational information only. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. The materials on this website are for your general educational information only. 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. 1997-2023 WestCMR. Returns are simple. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Canadian pipeline operator Enbridge Inc said on Monday it would acquire Aitken Creek natural gas storage facility in British Columbia (B.C.) 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. 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). In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. An integrated technology platform to enable better spine surgery. Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. PDF User Manual - Nuwave Cpap Rethink how you buy and sell surgical supplies. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. 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). BOX8-1Five Key Steps for Performing the XLIF Procedure 1. PDF NuVasive, Incorporated March 25, 2020 - Food and Drug Administration (This story corrected name of Globus Medical in the headline from Global Medical). At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. nuvasive product catalog pdf 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. Elizabeth Hofheinz, M.P.H., M.Ed. NuVasive is headquartered in San Diego, California, the US. Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. An official website of the United States government, : Excluding VAT and shipping. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. 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. PDF Document Title: Visual and Cosmetic Standards for Manufacturing 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). 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. Polini A, Pisignano D, Parodi M, et al. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. NuVasive Acquires Simplify Medical - NuVasive The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. Expected delivery: 3 weeks. COMPANY CONFIDENTIAL. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. Before sharing sensitive information, make sure you're on a federal government site. NV Dynamic Stimulation Clip and Inline Activator. List of devices made by the manufacturer NUVASIVE, INC. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P You should always talk to your healthcare professional for diagnosis and treatment.