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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295001829 | K070849 | 000 |
| 10603295001713 | K070849 | 000 |
| 10603295001720 | K070849 | 000 |
| 10603295001737 | K070849 | 000 |
| 10603295001744 | K070849 | 000 |
| 10603295001768 | K070849 | 000 |
| 10603295001775 | K070849 | 000 |
| 10603295001782 | K070849 | 000 |
| 10603295001799 | K070849 | 000 |
| 10603295001805 | K070849 | 000 |
| 10603295001812 | K070849 | 000 |
| 10603295001751 | K070849 | 000 |