The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Modified Synatomic Variable Fit Tibial Plateau.
| Device ID | K860133 |
| 510k Number | K860133 |
| Device Name: | MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Steve Wentworth |
| Correspondent | Steve Wentworth DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-14 |
| Decision Date | 1986-03-10 |