The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex Arc Hip Stem.
| Device ID | K090845 |
| 510k Number | K090845 |
| Device Name: | APEX ARC HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE SUITE 302 Raynham, MA 02767 |
| Contact | William Mccallum |
| Correspondent | William Mccallum OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE SUITE 302 Raynham, MA 02767 |
| Product Code | LZO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-27 |
| Decision Date | 2010-04-07 |
| Summary: | summary |