The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Preservation Unicondylar Tibia.
Device ID | K040268 |
510k Number | K040268 |
Device Name: | DEPUY PRESERVATION UNICONDYLAR TIBIA |
Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Abraham Wright |
Correspondent | Abraham Wright 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 | 2004-02-05 |
Decision Date | 2004-05-05 |
Summary: | summary |