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 |