The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Foundation Modular Tibial Baseplate.
| Device ID | K932425 |
| 510k Number | K932425 |
| Device Name: | FOUNDATION MODULAR TIBIAL BASEPLATE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J. D Webb |
| Correspondent | J. D Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-19 |
| Decision Date | 1994-07-22 |