510(k) K170910 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Medacta Anatomic Shoulder Prosthesis
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, Aug 16, 2017 |
| Received | Mar 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2019 | Medacta Usa Inc Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral frac Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.