The following data is part of a premarket notification filed by Omnilife Science with the FDA for Apex Hcla Acetabular Cup Liners.
| Device ID | K062489 |
| 510k Number | K062489 |
| Device Name: | APEX HCLA ACETABULAR CUP LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OMNILIFE SCIENCE 175 PARAMOUNT DR SUITE 302 Raynham, MA 02767 |
| Contact | Edward Cheal |
| Correspondent | Edward Cheal OMNILIFE SCIENCE 175 PARAMOUNT DR SUITE 302 Raynham, MA 02767 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2007-08-15 |
| Summary: | summary |