510(k) K010635 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
INTERLOK / HA COPELAND RESURFACING HEADS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Mar 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641
11-114642
11-114643
11-114644
11-114644S
11-114645
11-114646
11-114647
11-114648
11-114661
11-114662
11-114663
11-114664
11-114664S
11 Terminated |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.