510(k) K130661 ยท PHX Shoulder Prosthesis, Reverse Configuration
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 9, 2013 |
| Received | Mar 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2019 | Zimmer Biomet, Inc. Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613
00430900103
00434210613
00434210813
00434210817
00434210913
00434211013
00434211017
00434211113
00434211213
00434211217
00434211313
0043 Terminated |
KWT | None listed |
| Dec 30, 2013 | Zimmer, Inc. Trabecular Metal (TM) Reverse Glenosphere 36mm
Part 00-4349-036-11
The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheum Terminated |
KWT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.