The following data is part of a premarket notification filed by Omnlife Science with the FDA for Apex Knee Modular Tibia System.
| Device ID | K101994 |
| 510k Number | K101994 |
| Device Name: | APEX KNEE MODULAR TIBIA SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OMNLIFE SCIENCE 50 O'CONNELL WAY East Taunton, MA 02718 |
| Contact | Radhika Taunton |
| Correspondent | Radhika Taunton OMNLIFE SCIENCE 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 | 2010-07-15 |
| Decision Date | 2010-09-28 |
| Summary: | summary |