The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Peak Fx Hip Plate.
Device ID | K063509 |
510k Number | K063509 |
Device Name: | DEPUY PEAK FX HIP PLATE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
Contact | Rhonda Myer |
Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-20 |
Decision Date | 2007-01-04 |
Summary: | summary |