510(k) K002998 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
BIOMET BI-POLAR SHOULDER SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 6, 2000 |
| Received | Sep 26, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Biomet, Inc. Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156. Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.