510(k) K110791 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 2, 2011 |
| Received | Mar 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2013 | Zimmer, Inc. Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm
This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. h Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.