510(k) K133794 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
| Applicant | Depuy Mitek, A Johnson & Johnson Company, Raynham MA, US |
| Decision | Substantially Equivalent, Feb 4, 2014 |
| Received | Dec 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133794
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.