The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Gck Femoral And Tibial Components.
| Device ID | K070849 |
| 510k Number | K070849 |
| Device Name: | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | NPJ |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-06-26 |
| Summary: | summary |