510(k) K191146 ยท PHX Shoulder Prosthesis, Reverse Configuration
Humelock TiN Coated Glenosphere
| Applicant | Fx Shoulder USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jul 15, 2020 |
| Received | Apr 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2024 | FX SHOULDER Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.