510(k) K992119 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
BIO-MODULAR SHOULDER SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 13, 1999 |
| Received | Jun 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Extremities, Shoulders and Elbows
BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System
Product Usage:
Shoulder Replacement E Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.