The following data is part of a premarket notification filed by Omnlife Science with the FDA for Apex Hip System Bipolar Head, Model H3-822xx (od 38 To 43mm), H3-828xx (od44 To 60mm).
| Device ID | K100151 |
| 510k Number | K100151 |
| Device Name: | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | OMNLIFE SCIENCE 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti OMNLIFE SCIENCE 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 | 2010-01-19 |
| Decision Date | 2010-05-28 |
| Summary: | summary |