The following data is part of a premarket notification filed by Omnilife Science with the FDA for Apex Knee System.
| Device ID | K201611 |
| 510k Number | K201611 |
| Device Name: | Apex Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNIlife Science 480 Paramount Drive Raynham, MA 02767 |
| Contact | Dipti Dharia |
| Correspondent | Dipti Dharia OMNIlife Science 480 Paramount Drive Raynham, MA 02767 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2021-04-02 |