Regulatory

United Orthopedic Corporation Announces FDA Clearance for Vitamin E Highly Cross-Linked Polyethylene Hip Liner

IRVINE, Calif., Nov. 27, 2018 /PRNewswire/ -- United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration has cleared its vitamin E highly cross-linked polyethylene (E-XPETM) hip liner. The E-XPE™ is the new generation of highly cross-linked polyethylene blended with vitamin E to

By |2018-11-28T16:04:10+00:00November 28th, 2018|Regulatory|
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UK firm sold spinal implants that disintegrated

26 Nov 2018 / Hilary Osborne A UK company’s spinal implants that allegedly moved and eroded in patients, and which are at the centre of legal action, have highlighted potential weaknesses in the way in which some medical devices enter the market, an investigation has revealed. Documents seen by the Guardian show the plastic discs were

By |2018-11-27T20:49:46+00:00November 27th, 2018|Regulatory, Spine|
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Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System. The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency

By |2018-11-27T18:31:27+00:00November 27th, 2018|Regulatory, Spine|
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FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to modernize FDA’s 510(k) program

November 26, 2018 / FDA Statement Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices. Today, we’re announcing changes to modernize the FDA’s 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews. We’re pursuing these changes to help keep pace

By |2018-11-26T21:51:26+00:00November 26th, 2018|Regulatory|
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IMPLANET: CE Mark Clearance for the Jazz Cap System®, a Screw Securing Solution for Vertebral Fusion

November 20, 2018 BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News: IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, is announcing the award of CE marking for the Jazz Cap System®, developed to meet the constraints of vertebral fusion indications in adults.

By |2018-11-21T16:19:03+00:00November 21st, 2018|Regulatory|
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OrthoXel™ Orthopaedic Trauma Device Company Announce CE Mark Clearance Following FDA 510(k) for new Apex Femoral Nailing System

CORK, Ireland, Nov. 20, 2018 /PRNewswire/ -- OrthoXel is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXel is delighted to announce that following United States FDA 510k and CE mark clearance for the Apex Tibial Nailing System, the new Apex Femoral Nailing System has been granted European CE Mark, following

By |2018-11-21T15:51:17+00:00November 21st, 2018|Regulatory|
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Bio2 Technologies, Inc. Receives FDA IDE Approval to Begin Clinical Study of Resorbable Cervical Interbody Device for Spinal Fusion

WOBURN, Mass., Nov. 13, 2018 /PRNewswire/ -- Bio2 Technologies, Inc., a privately held orthopedics company, announced today that it received U.S. Food and Drug Administration ("FDA") approval to begin enrollment in an IDE clinical study to evaluate Vitrium as a cervical interbody fusion device.  Vitrium will be evaluated as a structural device that facilitates bone remodeling via a

By |2018-11-14T17:15:56+00:00November 14th, 2018|Regulatory|
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FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

SILVER SPRING, Md., Nov. 13, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead

By |2018-11-13T17:08:30+00:00November 13th, 2018|Regulatory, Top Stories|
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NuVasive’s Proprietary Porous PEEK™ Implant To Be Used In Flagship XLIF® Procedure

SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of its COHERE® Porous PEEK™ implant in eXtreme Lateral Interbody Fusion (XLIF®) surgical

By |2018-11-08T22:26:02+00:00November 8th, 2018|Regulatory, Spine|
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SpinalCyte Announces New International Patents

November 07, 2018 HOUSTON--(BUSINESS WIRE)--SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts (HDFs), today announced the issuance of new patents in Hong Kong and Europe. The company’s industry leading intellectual property in spine treatments now includes 35 U.S. and foreign patents issued with 41 patents

By |2018-11-07T22:02:32+00:00November 7th, 2018|Regulatory|
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Odysseus Medical Solutions 2018
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