Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System

Implantable Post-surgical Kinematic Measurement Knee Device

Canary Medical, Inc.

The following data is part of a De Novo classification by Canary Medical, Inc. with the FDA for Canary Tibial Extension With Canary Health Implanted Reporting Processor (chirp) System.

Pre-market Notification Details

DeNovo IDDEN200064
Device Name:Canary Tibial Extension With Canary Health Implanted Reporting Processor (CHIRP) System
ClassificationImplantable Post-surgical Kinematic Measurement Knee Device
Applicant Canary Medical, Inc. 2150 Western Parkway, Suite 202 Vancouver,  CA V6t 1v6
ContactNora C.r. York
Product CodeQPP  
CFR Regulation Number888.3600 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOrthopedic
Classification AdvisoryOrthopedic
TypeDirect
Date Received2020-10-19
Decision Date2021-08-27
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860003118351 DEN200064 000
00850015699023 DEN200064 000
00850015699030 DEN200064 000
00850015699047 DEN200064 000
00850015699054 DEN200064 000
00850015699061 DEN200064 000
00850015699078 DEN200064 000
00850015699085 DEN200064 000
00850015699092 DEN200064 000
00850015699108 DEN200064 000
00860003118306 DEN200064 000
00850015699009 DEN200064 000

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