The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Interface Acetabular System, Acetabular Insert +4 Offset.
| Device ID | K101976 |
| 510k Number | K101976 |
| Device Name: | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET |
| 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 |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-13 |
| Decision Date | 2010-09-14 |
| Summary: | summary |