510(k) K152754 ยท PHX Shoulder Prosthesis, Reverse Configuration
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, May 16, 2016 |
| Received | Sep 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152754
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2020 | Biomet, Inc. Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503
(10)814100, (01)00880304829503
(10)570640, (01)00880304829503
(10)728890, (01)00880304829503
(10)977300 Terminated |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.