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 |