510(k) K191318 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
AEQUALIS FLEX REVIVE Shoulder System
| Applicant | Tornier, Inc., Bloomington MN, US |
| Decision | Substantially Equivalent, Jun 14, 2019 |
| Received | May 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2023 | Tornier, Inc AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 Open, Classified |
KWS | None listed |
| Jun 28, 2023 | Tornier, Inc AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118 Open, Classified |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.