The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Trauma Internal Fixation Systems.
Device ID | K111663 |
510k Number | K111663 |
Device Name: | TRAUMA INTERNAL FIXATION SYSTEMS |
Classification | Plate, Fixation, Bone |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Suzana Otano |
Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | HRS |
Subsequent Product Code | HSB |
Subsequent Product Code | HTN |
Subsequent Product Code | HTY |
Subsequent Product Code | HWC |
Subsequent Product Code | JDW |
Subsequent Product Code | KTT |
Subsequent Product Code | LXT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-14 |
Decision Date | 2012-03-12 |
Summary: | summary |