The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Contour Unicompartmental Knee Prosthesis.
| Device ID | K000172 |
| 510k Number | K000172 |
| Device Name: | DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-20 |
| Decision Date | 2000-02-03 |