510(k) K201315 · PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PERFORM Humeral System Stem
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Sep 11, 2020 |
| Received | May 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2024 | Tornier, Inc Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty Open, Classified |
PAO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.