510(k) K023063 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
COMPREHENSIVE HUMERAL FRACTURE SYSTEM
| Applicant | Biomet Orthopedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 13, 2002 |
| Received | Sep 16, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | Zimmer Biomet, Inc. COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 Terminated |
KWT | None listed |
| Sep 30, 2011 | Biomet, Inc. Comprehensive Reverse Humeral Fracture Inserter
REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1.
Instrument that is attached to the trial prosthesis for placement in the prep Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.