The following data is part of a premarket notification filed by Scientific Research with the FDA for Orthofix Unreamed Tibial Nail System.
| Device ID | K912420 |
| 510k Number | K912420 |
| Device Name: | ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SCIENTIFIC RESEARCH 1220 19TH ST. N.W. SUITE 202 Washington, DC 20036 |
| Contact | Bruce K Bernard |
| Correspondent | Bruce K Bernard SCIENTIFIC RESEARCH 1220 19TH ST. N.W. SUITE 202 Washington, DC 20036 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-09-23 |