K082468 is an FDA 510(k) clearance for the APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60). This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on February 18, 2009, 175 days after receiving the submission on August 27, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K082468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2008 |
| Decision Date | February 18, 2009 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |