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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Post-Surgical Kinematic Measurement Knee Device
510(k) Number K223803
Device Name Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Applicant
Canary Medical USA, LLC
2710 Loker Ave. W., Suite 350
Carlsbad,  CA  92010
Applicant Contact Kevin Leung
Correspondent
Canary Medical USA, LLC
2710 Loker Ave. W., Suite 350
Carlsbad,  CA  92010
Correspondent Contact Kevin Leung
Regulation Number888.3600
Classification Product Code
QPP  
Date Received12/19/2022
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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