The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex-lnk Poly Acetabular Cup Liners.
| Device ID | K073150 |
| 510k Number | K073150 |
| Device Name: | APEX-LNK POLY ACETABULAR CUP LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | Edward J Cheal |
| Correspondent | Edward J Cheal OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-08 |
| Decision Date | 2008-02-27 |
| Summary: | summary |