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 |