The following data is part of a premarket notification filed by Omnilife Science Inc. with the FDA for Omni Skirted Heads.
| Device ID | K152919 |
| 510k Number | K152919 |
| Device Name: | OMNI Skirted Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | OMNILIFE SCIENCE INC. 50 O'CONNELL WAY SUITE 10 East Taunton, MA 02718 |
| Contact | Vani Sindwani |
| Correspondent | Christina Flores OMNILIFE SCIENCE INC. 50 O'CONNELL WAY SUITE 10 East Taunton, MA 02718 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-02 |
| Decision Date | 2016-03-10 |
| Summary: | summary |