510(k) K000817 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
OMEGA II MODULAR TOTAL HIP SYSTEM
| Applicant | Osteoimplant Technology, Inc., Hunt Valley MD, US |
| Decision | Substantially Equivalent, Jun 8, 2000 |
| Received | Mar 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000817
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2008 | Encore Medical, Lp Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758.
Designed to ensure the proper anteversion and femoral head orientation in the acetabul Terminated |
JDI | None listed |
| Jul 23, 2007 | Encore Medical, Lp ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical Terminated |
JDI | None listed |
| Jul 23, 2007 | Encore Medical, Lp ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical Terminated |
JDI | None listed |
| Jul 23, 2007 | Encore Medical, Lp ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; dis Terminated |
JDI | None listed |
| Jul 23, 2007 | Encore Medical, Lp ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; d Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.