510(k) K260104 · QHE Shoulder Arthroplasty Implantation System
Signature ONE System
| Applicant | Orthosoft Inc. (d/b/a) Zimmer CAS, Montreal, CA |
| Decision | Substantially Equivalent, Feb 4, 2026 |
| Received | Jan 13, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260104
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.