510(k) K101126 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
| Applicant | Core Essence Orthopaedics, Inc., Ft Washington PA, US |
| Decision | Substantially Equivalent, Dec 2, 2010 |
| Received | Apr 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101126
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.