The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Knee System.
| Device ID | K923277 |
| 510k Number | K923277 |
| Device Name: | FOUNDATION KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. P.O. BOX 33 Red Rock, TX 78662 |
| Contact | Webb |
| Correspondent | Webb ENCORE ORTHOPEDICS, INC. P.O. BOX 33 Red Rock, TX 78662 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1993-02-09 |