The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Universal And Troch Entry Femoral Nailing Systems Line Extension.
| Device ID | K111444 |
| 510k Number | K111444 |
| Device Name: | UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-24 |
| Decision Date | 2011-06-22 |
| Summary: | summary |