The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex Revision Knee Systems.
| Device ID | K112891 |
| 510k Number | K112891 |
| Device Name: | APEX REVISION KNEE SYSTEMS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNI LIFE SCIENCE, INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| Contact | Christine Nassif |
| Correspondent | Christine Nassif OMNI LIFE SCIENCE, INC. 50 O'CONNELL WAY 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 | 2011-09-30 |
| Decision Date | 2012-02-29 |
| Summary: | summary |