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. Based on review of publicly available materials at the time of this release. 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. Quantity: 4. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. DLA Piper is serving as NuVasives legal counsel. Expected delivery: 2 weeks. multi-level pathologies. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. 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. Intelligently designed for fusion. D. Device Description. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. 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 . You don't have to face this journey alone. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. %%EOF The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. All quotes delayed a minimum of 15 minutes. Spine 2020;45(14):944-51. Learn how intelligent surgery can change your practice. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. 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). NuVasive provides patient support and surgeon education. Headquarters United States of America. At NuVasive, we transform surgery, advanced care, and change lives. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. Photos are for illustration purposes only and may not depict the exact item. Excluding VAT and shipping. Make sure cookies are enabled in your browser. PLoS ONE 2011;6(10):1-8. 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. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. The .gov means its official.Federal government websites often end in .gov or .mil. Elizabeth Hofheinz, M.P.H., M.Ed. 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. 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. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. 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. 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 FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Do not implant more than two devices in a patient at once. The materials on this website are for your general educational information only. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. Expected delivery: 3 weeks. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. We do not practice medicine or provide medical services or advice as a part of this website. Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. JavaScript seems to be disabled in your browser. Sign in to add this product to your favorites! Prices excluding VAT and shipping. NV Dynamic Stimulation Clip and Inline Activator. 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. gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. 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. Expected delivery: 3 weeks. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. 2. Neurocare Products. NuVasive is headquartered in San Diego, California, the US. Disc space preparation 5. The discussions between the companies are preliminary and there is no certainty that a deal will be reached, the sources added, requesting anonymity because the matter is confidential. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. It will also discuss the Simplify Medical transaction at that time. We do not practice medicine or provide medical services or advice as a part of this website. Retroperitoneal access 3. The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. 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 The industry leader for online information for tax, accounting and finance professionals. 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. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. Becoming the number one partner in pediatrics. All products sold by WestCMR are in-date. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. 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. 789 0 obj <> endobj Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Excluding VAT and shipping. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. 50 - 99 pieces - 8,75. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. This service located at Oisto.com is a website owned and operated by Oisto. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. Copyright 2022 Oisto. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. Website www.nuvasive.com. Reimagine cervical spine surgery. Osteocel is human tissue donated specifically for human clinical use. function gtag(){dataLayer.push(arguments);} Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE Implant insertion WestCMR does not provide advice, training, or clinical support. %PDF-1.5 % Appropriate patient positioning 2. Expected delivery: 3 weeks. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. Information you read on this website cannot replace the relationship that you have with your healthcare professional. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; Excluding VAT and shipping. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. 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 materials on this website are for your general educational information only. 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. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 The subject Prices excluding VAT and shipping. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. NuVasive offers solutions to alleviate patient symptoms. Thu, October 4th, 2018. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. 1 Terran J, Schwab F, Shaffrey CI, et al. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. 888 0 obj <>stream All Trademarks referred to are the property of their respective owners. (This story corrected name of Globus Medical in the headline from Global Medical). ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. NuVasive offers solutions to alleviate patient symptoms. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. The Sage Lateral Plate System If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). For more information, please visit www.nuvasive.com. 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. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. NuVasive provides patient support and surgeon education. Peer-to-peer discussion between Drs. This power bank is suitable for charging any device. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. An integrated technology platform to enable better spine surgery. Three New Biologic Products for Spine Surgery. 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. Forward-Looking Statements 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 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. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. or more while undergoing treatment, and. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Price: $5.00 per kit. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. 1Simplify Cervical Artificial Disc P200022. Polini A, Pisignano D, Parodi M, et al. Information you read on this website cannot replace the relationship that you have with your healthcare professional. $1,299.99. List of devices made by the manufacturer NUVASIVE, INC. The site is secure. 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). Neurostimulators & Components. The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. 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. Do not implant in patients under 18 years of age. Excluding VAT and shipping. 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 offers solutions to alleviate patient symptoms. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. Our Standards: The Thomson Reuters Trust Principles. Open the catalog to page 2 What is causing my pain? At NuVasive, we aspire to change a patients life every minute. Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology.

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