FDA 510(k) Application Details - K220413

Device Classification Name	More FDA Info for this Device
510(K) Number	K220413
Device Name	Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Applicant	Canary Medical USA LLC 2710 Loker Ave. West, Suite 350 Carlsbad, CA 92010 US 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	02/14/2022
Decision Date	06/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review