510(k) K023743 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 23, 2003 |
| Received | Nov 7, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K023743
| 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 |
| Aug 29, 2016 | Smith & Nephew, Inc. TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR,
REF NUMBERS:
71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, Terminated |
KWY | None listed |
| Aug 29, 2016 | Smith & Nephew, Inc. TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR,
REF NUMBERS:
71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 7132 Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.