The following data is part of a premarket notification filed by Omnilife Science Inc. with the FDA for Apex Knee System, Apex All Poly Tibia.
| Device ID | K111062 |
| 510k Number | K111062 |
| Device Name: | APEX KNEE SYSTEM, APEX ALL POLY TIBIA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNILIFE SCIENCE INC. 50 O'CONNELL WAY SUITE #10 East Taunton, MA 02718 |
| Contact | Christine Nassif |
| Correspondent | Christine Nassif OMNILIFE SCIENCE INC. 50 O'CONNELL WAY SUITE #10 East Taunton, MA 02718 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-07-13 |
| Summary: | summary |