FDA 510(k) Application Details - DEN200064

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200064
Device Name	Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Applicant	Canary Medical, Inc. 2150 Western Parkway, Suite 202 Vancouver V6T 1V6 CA Other 510(k) Applications for this Company
Contact	Nora C.R. York Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2020
Decision Date	08/27/2021
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review