510(k) K183696 ยท PHX Shoulder Prosthesis, Reverse Configuration
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Jan 30, 2019 |
| Received | Dec 31, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Tornier, Inc Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.