The following data is part of a premarket notification filed by Omnlife Science with the FDA for Apex Modular Acctabular Cup (now Named Apex Interface Acetabular System).
| Device ID | K112779 |
| 510k Number | K112779 |
| Device Name: | APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX 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 | Christine Nassif |
| Correspondent | Christine Nassif OMNLIFE SCIENCE 50 O'CONNELL WAY SUITE 10 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 | 2011-09-26 |
| Decision Date | 2011-12-02 |
| Summary: | summary |