The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Femoral Nailing Sytem.
| Device ID | K973944 |
| 510k Number | K973944 |
| Device Name: | ORTHOFIX FEMORAL NAILING SYTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOFIX SRL 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan ORTHOFIX SRL 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-16 |
| Decision Date | 1997-12-19 |
| Summary: | summary |