510(k) K141006 ยท PHX Shoulder Prosthesis, Reverse Configuration
RSP HUMERAL SOCKET INSERT
| Applicant | Djo Global, Austin TX, US |
| Decision | Substantially Equivalent, Jun 5, 2014 |
| Received | Apr 18, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2020 | Encore Medical, LP RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 Open, Classified |
PHX | None listed |
| Aug 7, 2020 | Encore Medical, LP RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440 Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.