FDA.reportPublic FDA data

De Novo DEN160062

Device
IlluminOss Bone Stabilization System
Contact
fred tobia
De Novo number
DEN160062
Product code
QAD
Regulation
888.3023
Classification name
rod, fixation, intramedullary and accessories, in-vivo cured, light-activated
Decision
granted (DENG)
Decision date
2017-12-19
Date received
2016-12-28
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
QAD
Device name
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
Medical specialty
Orthopedic
Device class
2
Regulation
888.3023
Implant
Y
Life sustain/support
N