FDA.reportPublic FDA data

De Novo DEN180065

Device
OGmend Implant System
Contact
bob luzzi
De Novo number
DEN180065
Product code
QAC
Regulation
888.3043
Classification name
screw sleeve bone fixation device
Decision
granted (DENG)
Decision date
2020-05-01
Date received
2018-12-13
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
QAC
Device name
Screw Sleeve Bone Fixation Device
Medical specialty
Orthopedic
Device class
2
Regulation
888.3043
Implant
Y
Life sustain/support
N