510(k) K212560 · QHE Shoulder Arthroplasty Implantation System
Signature ONE System
| Applicant | Orthosoft Inc (D/B/A Zimmer Cas), Montreal, CA |
| Decision | Substantially Equivalent, Oct 12, 2021 |
| Received | Aug 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212560
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.