510(k) K152966 ยท PHX Shoulder Prosthesis, Reverse Configuration
Aequalis Fx2
| Applicant | Tornier S.A.S., Montbonnot Saint Martin, FR |
| Decision | Substantially Equivalent, Jan 14, 2016 |
| Received | Oct 7, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2016 | Tornier, Inc Aequalis Fx2 implant parts and instrument trays.
Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.