510(k) K073412 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
GRYPHON BR AND HEALIX BR ANCHORS
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Raynham MA, US |
| Decision | Substantially Equivalent, Jan 17, 2008 |
| Received | Dec 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2011 | DePuy Mitek, Inc., a Johnson & Johnson Co. DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD
Product Code: 210811
Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acrom Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.