The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Titanium Nailing Systems.
| Device ID | K053261 |
| 510k Number | K053261 |
| Device Name: | ORTHOFIX TITANIUM NAILING SYSTEMS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOFIX SRL 632 DUNDEE DRIVE Wilmington, NC 28405 |
| Contact | Candace F Cederman |
| Correspondent | Candace F Cederman ORTHOFIX SRL 632 DUNDEE DRIVE Wilmington, NC 28405 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-22 |
| Decision Date | 2005-12-12 |
| Summary: | summary |