510(k) K193373 · PHX Shoulder Prosthesis, Reverse Configuration
Comprehensive® Reverse Shoulder
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 15, 2020 |
| Received | Dec 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552,
180553, 180554, 180555, 180556, 180557, 180558, 180559,
180560, 180562 - Product Usage: in Terminated |
KWS | None listed |
| Sep 2, 2020 | Biomet, Inc. Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis
item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder p Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.