The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Anatomic Modular Knee (amk) System.
Device ID | K864671 |
510k Number | K864671 |
Device Name: | ANATOMIC MODULAR KNEE (AMK) SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Steven J Wentworth |
Correspondent | Steven J Wentworth DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
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 | 1986-12-02 |
Decision Date | 1987-02-06 |