nuvasive product catalog pdf
Innovation in Musculoskeletal Solutions | Globus Medical Prices excluding VAT and shipping. Expected delivery: 3 weeks. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. To learn more, visit www.simplifymedical.com. If so, do not buy this item unless you are an authorized purchaser. Polini A, Pisignano D, Parodi M, et al. Sign in to add this product to your favorites! Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. All quotes delayed a minimum of 15 minutes. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. 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. 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. endstream endobj startxref 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream You should always talk to your healthcare professional for diagnosis and treatment. We do not practice medicine or provide medical services or advice as a part of this website. This service located at Oisto.com is a website owned and operated by Oisto. endif; ?> (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P Information you read on this website cannot replace the relationship that you have with your healthcare professional. 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 . These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. 1997-2023 WestCMR. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Elizabeth Hofheinz, M.P.H., M.Ed. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. The industry leader for online information for tax, accounting and finance professionals. This power bank is suitable for charging any device. Duan R, Barbieri D, Luo X, et al. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. ALIF - NuVasive ET / 1:30 p.m. PT to discuss these results. 2Data on file. DLA Piper is serving as NuVasives legal counsel. NuVasive introduces new Reline 3D posterior fixation system 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 . Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. Our Standards: The Thomson Reuters Trust Principles. 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. NuVasive provides patient support and surgeon education. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. NuVasive Inc Company Profile - GlobalData Expected delivery: 3 weeks. Get your money back!. About NuVasive Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. Make sure cookies are enabled in your browser. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. Height 25cm, diameter 7cm - Volume: 500 ml. Intelligently designed for fusion. 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. var site_url = "https://www.medicaldevices24.com/"; PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd Do not implant more than two devices in a patient at once. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. 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. %%EOF Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. We do not practice medicine or provide medical services or advice as a part of this website. 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 its C360 portfolio. NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures NuVasive is developing the operating room of the future. 1.0 Purpose. PDF User Manual - Nuwave Cpap $1,299.99. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. 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. 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. Expected delivery: 3 weeks. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for At NuVasive, we transform surgery, advanced care, and change lives. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. *Data on file. Please close the page and access the Company Store via Okta. Potential Biocompatibility Concerns with NuVasive Specialized There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. PDF Document Title: Visual and Cosmetic Standards for Manufacturing (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 . Disc space preparation 5. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. JavaScript seems to be disabled in your browser. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. 789 0 obj <> endobj 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. NuVasive is headquartered in San Diego, California, the US. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. $650.00. 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. window.dataLayer = window.dataLayer || []; 2020 - NuVasive offers solutions to alleviate patient symptoms. Malone, H., Mundis, G. M., Jr., Collier, M, et al. Returns are simple. 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). Surgical efficiency meets reliable versatility. The materials on this website are for your general educational information only. Headquarters United States of America. Retroperitoneal access 3. The .gov means its official.Federal government websites often end in .gov or .mil. 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. 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. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. 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. 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. Three New Biologic Products for Spine Surgery UPDATE: Potential Concerns with NuVasive Precice Devices Unhappy? Based on review of publicly available materials at the time of this release. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Excluding VAT and shipping. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. (This story corrected name of Globus Medical in the headline from Global Medical). At NuVasive, we transform surgery, advanced care, and change lives. At NuVasive, we aspire to change a patients life every minute. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. 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.. Biomater Sci 2018;6:136-45. 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. NuVasive is the fastest growing, full-line spine company. All rights reserved. San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory See here for a complete list of exchanges and delays. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. NuVasive offers solutions to alleviate patient symptoms. 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. Expected delivery: 2 weeks. Prices excluding VAT and shipping. Rethink how you buy and sell surgical supplies. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). The materials on this website are for your general educational information only. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. var base_url = "https://www.medicaldevices24.com/"; 0 Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. All products | NuVasive Webshop 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. NuVasive Acquires Simplify Medical - NuVasive NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. 2. As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. 1 Terran J, Schwab F, Shaffrey CI, et al. You have not been assigned a username and password. Excluding VAT and shipping. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. The Sage Lateral Plate System NuVasive funded the upfront payment at closing using available cash on hand. Learn how intelligent surgery can change your practice. PCF - NuVasive - PDF Catalogs | Technical Documentation The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. Surgical efficiency. The materials on this website are for your general educational information only. Read the press release CODE: NS10000565. 5. You should always talk to your healthcare professional for diagnosis and treatment. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. 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. 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). 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. The store will not work correctly in the case when cookies are disabled. An integrated technology platform to enable better spine surgery. 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-