510(k) K231448 ยท LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
TANDEM Hip System
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 19, 2023 |
| Received | May 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | Smith & Nephew, Inc. Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System. Open, Classified |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.