510(k) K132239 ยท PHX Shoulder Prosthesis, Reverse Configuration
COMPREHENSIVE REVERSE SHOULDER SCREWS
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 6, 2013 |
| Received | Jul 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2021 | Biomet, Inc. Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation. Terminated |
PHX | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.