510(k) K062693 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
GLADIATOR BIPOLAR SYSTEM
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Sep 29, 2006 |
| Received | Sep 11, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head Terminated |
KWY | None listed |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head Terminated |
KWY | None listed |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head Terminated |
KWY | None listed |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head Terminated |
KWY | None listed |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head Terminated |
KWY | None listed |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.