The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Gck Tibial Components.
| Device ID | K070267 |
| 510k Number | K070267 |
| Device Name: | DEPUY GCK TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-08-17 |
| Summary: | summary |