The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Amk All Polyethylene Posterior Stablilized Tibial Tray.
| Device ID | K943299 |
| 510k Number | K943299 |
| Device Name: | DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. 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 | 1994-07-09 |
| Decision Date | 1995-01-27 |