510(k) K130539 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Raynham MA, US |
| Decision | Substantially Equivalent, May 21, 2013 |
| Received | Mar 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130539
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.