510(k) K122698 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
| Applicant | Tornier S.A.S., Bloomington MN, US |
| Decision | Substantially Equivalent, Jan 8, 2013 |
| Received | Sep 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2021 | Tornier, Inc Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile
Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. Terminated |
KWS | None listed |
| Oct 18, 2019 | Tornier, Inc Aequalis Ascend Flex Humeral Stem:
Part Number UDI
DWF601A 3700386944475
DWF601B 3700386944482
DWF601C 3700386944499
DWF602A 3700386944505
DWF602B 3700386944512
DWF602C 3700386944529
DWF603A 370038694 Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.