The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Omknee System.
| Device ID | K854883 |
| 510k Number | K854883 |
| Device Name: | OMKNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ORTHOMET, INC. 4230 TRENTON LN. Plymouth, MN 55441 |
| Contact | Karen Young |
| Correspondent | Karen Young ORTHOMET, INC. 4230 TRENTON LN. Plymouth, MN 55441 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-06 |
| Decision Date | 1986-02-18 |