The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Orthofix Tibial Nailing System.
| Device ID | K961027 |
| 510k Number | K961027 |
| Device Name: | ORTHOFIX TIBIAL NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ORTHOFIX, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan ORTHOFIX, INC. 12300 TWINBROOK PKWY. 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 | 1996-03-14 |
| Decision Date | 1996-05-08 |
| Summary: | summary |