510(k) K191561 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech Equinoxe Humeral Augmented Trays
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Aug 20, 2019 |
| Received | Jun 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2021 | Exactech, Inc. Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray:
(1) HAT STD Left Tray Trial, Cat. Completed |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.