The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Graduated Compartmental Knee (gck).
| Device ID | K061648 |
| 510k Number | K061648 |
| Device Name: | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | NPJ |
| Subsequent Product Code | HRY |
| Subsequent Product Code | KRR |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2006-09-11 |
| Summary: | summary |