The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Amk Total Knee System W/du Pont Enhanced Uhmwpe.
| Device ID | K910992 |
| 510k Number | K910992 |
| Device Name: | AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Stephen J Peoples |
| Correspondent | Stephen J Peoples DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1992-08-10 |