510(k) K953510 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 9, 1995 |
| Received | Jul 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.