510(k) K161742 ยท PHX Shoulder Prosthesis, Reverse Configuration
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Nov 15, 2016 |
| Received | Jun 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161742
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | Tornier, Inc TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 Open, Classified |
KWS | None listed |
| Oct 13, 2023 | Tornier, Inc stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 Open, Classified |
PHX | None listed |
| May 3, 2022 | Tornier, Inc Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit Open, Classified |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.