510(k) K223833 · PHX Shoulder Prosthesis, Reverse Configuration
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 14, 2023 |
| Received | Dec 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223833
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2025 | Exactech, Inc. Exactech Equinoxe, Reverse Shoulder Humeral Liners,
322-38-00 (145-DEG PE 38MM HUM LINER +0),
REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5),
REF:322-42-00 (145-DEG PE 42MM HUM LINER +0),
REF: 322-4 Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.