FDA.reportPublic FDA data

De Novo DEN200064

Device
Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Contact
nora c.r. york
De Novo number
DEN200064
Product code
QPP
Regulation
888.3600
Classification name
implantable post-surgical kinematic measurement knee device
Decision
granted (DENG)
Decision date
2021-08-27
Date received
2020-10-19
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
QPP
Device name
Implantable Post-Surgical Kinematic Measurement Knee Device
Medical specialty
Orthopedic
Device class
2
Regulation
888.3600
Implant
Y
Life sustain/support
N