510(k) K073688 ยท PHX Shoulder Prosthesis, Reverse Configuration
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 29, 2008 |
| Received | Dec 28, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073688
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2012 | Exactech, Inc. Equinoxe Reverse Shoulder Fracture Adapter Tray Screw
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.