510(k) K111716 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
KNOTLESS SUTURE FIXATION SYSTEM
| Applicant | Core Essence Orthopaedics, Ft. Washington PA, US |
| Decision | Substantially Equivalent, Nov 10, 2011 |
| Received | Jun 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111716
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.