FDA.reportPublic FDA data

De Novo DEN220012

Device
Tornier Pyrocarbon Humeral Head
Contact
loucinda bjorklund
De Novo number
DEN220012
Product code
QKW
Regulation
888.3695
Classification name
shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis
Decision
granted (DENG)
Decision date
2022-12-16
Date received
2022-02-08
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Post-NSE

Current FDA Classification#

Product code
QKW
Device name
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Medical specialty
Orthopedic
Device class
2
Regulation
888.3695
Implant
Y
Life sustain/support
N