510(k) K130917 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
HEALIX ADVANCE KNOTLESS BR ANCHOR
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Raynham MA, US |
| Decision | Substantially Equivalent, May 24, 2013 |
| Received | Apr 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130917
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | DePuy Mitek, Inc., a Johnson & Johnson Co. Healix Knotless ADV BR 4.75 Suture Anchor Terminated |
MAI | None listed |
| Nov 4, 2019 | DePuy Mitek, Inc., a Johnson & Johnson Co. Healix Knotless ADV BR 5.5 Suture Anchor Terminated |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.