510(k) K213827 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)
| Applicant | Smith & Nephew, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Mar 11, 2022 |
| Received | Dec 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213827
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.