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 |