FDA.reportPublic FDA data

De Novo DEN220030

Device
RemeOs™ Screw LAG Solid
Contact
mari ruotsalainen
De Novo number
DEN220030
Product code
QJD
Regulation
888.3041
Classification name
absorbable metallic bone fixation fastener
Decision
granted (DENG)
Decision date
2023-03-29
Date received
2022-05-04
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
QJD
Device name
Absorbable Metallic Bone Fixation Fastener
Medical specialty
Orthopedic
Device class
2
Regulation
888.3041
Implant
Y
Life sustain/support
Y