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The Food and Drug Administration granted 43 orthopedic- and spine-related device clearances in January, according to an FDA report.
FH Orthopedics has received FDA clearance for the CoLS PEEK fixation screws for use during the CoLS technique for tendon graft fixation to the femur and tibia during ACL and PCL reconstruction, according to a company news release.
Interventional Spine, an Irvine, Calif.-based spine device company, has received FDA clearance for its Opticage Expandable Intervertebral Body Fusion device, according to a company news release.
Medtronic received FDA clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer, according to a company news release.
The Food and Drug Administration sent a letter to Johnson & Johnson's DePuy Orthopaedics, dated Dec. 8, warning the company that several of its hip, knee and joint replacement products were improperly marketed, according to a Wall Street Journal news report.
The Food and Drug Administration granted 56 orthopedic- and spine-related device clearances in December, according to an FDA report.
The Food and Drug Administration granted 26 spine-related 510(k) clearances in December, according to an FDA report.
Last week, the FDA announced a new Risk Evaluation and Mitigation Strategy for transmucosal fentanyl products that places the same regulations on BioDelivery Sciences International's Pain Relief Patch Onsolis as on other similar drugs, according to a news release.
Published in Pain Management
RoG Sports Medicine, an Orland Park, Ill.-based orthopedic implant company, recently received FDA clearance for its RoG Suture Anchor made of Zeniva polyetheretherketone, according to a Solvay Advanced Polymers news release.
The Food and Drug Administration granted 21 spine-related devices 510(k) clearance in November, according to an FDA report.
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