510(k) K213349 ยท PHX Shoulder Prosthesis, Reverse Configuration
Catalyst R1 Reverse Shoulder System
| Applicant | Catalyst Orthoscience, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Jun 23, 2022 |
| Received | Oct 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213349
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.