The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex Module Hip System Biolox Delta Femoral Head.
| Device ID | K101451 |
| 510k Number | K101451 |
| Device Name: | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-25 |
| Decision Date | 2010-06-22 |
| Summary: | summary |