The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Synatomic Variable Fit Tibial Plateau.
| Device ID | K851341 |
| 510k Number | K851341 |
| Device Name: | SYNATOMIC VARIABLE FIT TIBIAL PLATEAU |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/composite |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Judith Dermody |
| Correspondent | Judith Dermody DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KYK |
| CFR Regulation Number | 888.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-03 |
| Decision Date | 1985-07-15 |