The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex Knee System.
| Device ID | K060192 |
| 510k Number | K060192 |
| Device Name: | APEX KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE SUITE 302 Raynham, MA 02767 |
| Contact | Edward J Cheal |
| Correspondent | Edward J Cheal OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE SUITE 302 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 | 2006-01-25 |
| Decision Date | 2006-06-15 |
| Summary: | summary |