The following data is part of a premarket notification filed by Omnilife Science with the FDA for Apex Revision Knee System.
| Device ID | K153437 |
| 510k Number | K153437 |
| Device Name: | Apex Revision Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNILIFE SCIENCE 50 O'CONNELL WAY SUITE 10 East Taunton, MA 02718 |
| Contact | Christina Rovaldi |
| Correspondent | Christina Rovaldi OMNILIFE SCIENCE 50 O'CONNELL WAY SUITE 10 East Taunton, MA 02718 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2015-12-21 |