510(k) K172502 ยท PHX Shoulder Prosthesis, Reverse Configuration
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 3, 2018 |
| Received | Aug 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | Zimmer Biomet, Inc. COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S
115331
115330S
115330
110040610
110040620
010000589
CP561861
PM0001456
PM551047
PM551063
PM555137
PM555160
PM555209
PM555 Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.