The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Fracture And Fusion Plating System.
| Device ID | K093474 |
| 510k Number | K093474 |
| Device Name: | DEPUY FRACTURE AND FUSION PLATING SYSTEM |
| 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 |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2010-02-02 |
| Summary: | summary |