510(k) K102951 ยท PHX Shoulder Prosthesis, Reverse Configuration
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Nov 4, 2010 |
| Received | Oct 5, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102951
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2012 | Exactech, Inc. Equinoxe Fixed Angle Replicator Plate
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWS | None listed |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Reverse Glenosphere Locking Screw
Intended for Primary and Reverse Total Shoulder Arthroplasty. Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.