510k
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Ortho Kinematics Receives FDA 510(k) Clearance for KineGraph VMA System
AUSTIN, Texas–(BUSINESS WIRE)–Ortho Kinematics‚ a private company focused on revolutionizing spine motion analysis, announced receiving 510(k) clearance from the U.S.…
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26 Spine Devices Receive FDA 510(k) Clearance in December Featured
The Food and Drug Administration granted 26 spine-related 510(k) clearances in December, according to an FDA report. 1. Acculif TL-PEEK IBF…
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FDA seeks more info from BioMimetic
BioMimetic Therapeutics Inc. (Nasdaq: BMTI) was dealt a setback Tuesday when it learned the Food and Drug Administration did not approve its application…
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Bill Would Require More Monitoring of Implants
Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that…
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39 Orthopedic & Spine Devices Receives FDA 510(k) Clearance in November
1. Nano Suture Anchor from Linatec Corporation. 2. Leucadia MIS Pedicle Screw System from Phygen. 3. Aequalis Shoulder System from Tornier 4. Ascension…
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MedShape Solutions Announces FDA 510(k) Clearance of Innovative Ankle Fusion Device
ATLANTA, Aug. 9, 2011 /PRNewswire/ — MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, today announced its new…
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Hospitals
IOM Calls 510(k) Process “Flawed”, Recommends FDA Develop New System
The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system.…
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Hospitals
Medical device review took the FDA 37% longer in 2010 than 2006
MASSDEVICE ON CALL — Medical device consulting firm Emergo Group released results from a study of the U.S. Food &…
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ORTHOCON®, Inc. Receives 510(k) Clearance to Market HEMASORB Apply™
IRVINGTON, N.Y., June 1, 2011 /PRNewswire/ — ORTHOCON®, Inc., a privately-held therapeutic device company, today announced that the Food and Drug Administration…
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Stryker Receives FDA 510(K) Clearance for Shapematch® Cutting Guides
Kalamazoo, Michigan – May 24, 2011 – Stryker Orthopaedics, a division of Stryker Corporation (NYSE:SYK), today announced that its ShapeMatch…
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Medyssey Spine Receives 510(k) Clearance for Its LP Cage(TM) Posterior Lumbar Interbody Fusion System
CHICAGO, April 13, 2011 /PRNewswire/ — Medyssey Co., Ltd., the parent company of Medyssey Spine, a spinal implant manufacturer focused on commercializing products…
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Biologics
FDA makes ReGen 510(k) rescission final
ReGen Biologics Inc. reiterates its plan to seek regulatory and legal options for marketing its Menaflex knee implant, which the…
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Alphatec Spine Receives 510(k) Clearance for Solus System
Alphatec Holdings has received 510(k) clearance from the FDA for its Solus Anterior Lumbar Interbody Fusion system, according to a…
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Minnesota senators recruit buddies to pressure FDA over 510(k)
As the duly elected representatives of the great state of Minnesota, Sens. Amy Klobuchar and Al Franken along with Rep.…
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Medtronic Announces CD HORIZON® System 510k Pedicle Screw Clearance for Adolescent Idiopathic Scoliosis
MEMPHIS, TN – Dec. 2, 2010 – Medtronic (NYSE: MDT) announced today it received clearance to treat adolescent idiopathic scoliosis…
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