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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name implantable post-surgical kinematic measurement knee device
De Novo Number DEN200064
Device Name Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Requester
canary medical, inc.
2150 western parkway, suite 202
vancouver,  CA v6t 1v6
Contact nora c.r. york
Regulation Number888.3600
Classification Product Code
QPP  
Date Received10/19/2020
Decision Date 08/27/2021
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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