The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex Hip System Bipolar Head, Model H3-822xx And H3-828yy, Xx=od In [mm] (38-43), Yy=od In [mm](44-60).
| Device ID | K082468 |
| 510k Number | K082468 |
| Device Name: | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | William Mccallum |
| Correspondent | William Mccallum OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-27 |
| Decision Date | 2009-02-18 |
| Summary: | summary |