The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Anatomic Modular Knee (amk) Congruency Posterior Stabilized Tibial Insert.
| Device ID | K954684 |
| 510k Number | K954684 |
| Device Name: | DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | David A Kotkovetz |
| Correspondent | David A Kotkovetz DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE 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 | 1995-10-11 |
| Decision Date | 1996-01-26 |