510(k) K111746 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 15, 2011 |
| Received | Jun 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2018 | Biomet, Inc. Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.