The following data is part of a premarket notification filed by Omnlife Science with the FDA for Omni Interface Acetabular System.
| Device ID | K142201 |
| 510k Number | K142201 |
| Device Name: | OMNI Interface Acetabular System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OMNLIFE SCIENCE 50 O'CONNELL WAY SUITE 10 East Taunton, MA 02718 |
| Contact | Vani Sindwani |
| Correspondent | Vani Sindwani OMNLIFE SCIENCE 50 O'CONNELL WAY SUITE 10 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-11 |
| Decision Date | 2015-01-26 |
| Summary: | summary |