The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex-lnk Acetabular Insert, E, Apex-lnk Acetabular Insert, F, Apex-lnk.
| Device ID | K100555 |
| 510k Number | K100555 |
| Device Name: | APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OMNI LIFE SCIENCE, INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| Contact | Radhika Pondicherry |
| Correspondent | Radhika Pondicherry OMNI LIFE SCIENCE, INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| 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 | 2010-03-01 |
| Decision Date | 2010-03-29 |
| Summary: | summary |