FDA.reportPublic FDA data

De Novo DEN200010

Device
Spineology Interbody Fusion System
Contact
andrew adams
De Novo number
DEN200010
Product code
OQB
Regulation
888.3085
Classification name
intervertebral body graft containment device
Decision
granted (DENG)
Decision date
2020-09-18
Date received
2020-02-19
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
OQB
Device name
Intervertebral Body Graft Containment Device
Medical specialty
Orthopedic
Device class
2
Regulation
888.3085
Implant
Y
Life sustain/support
N