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510(k) K220413

Device
Canary Tibial Extension (CTE) With Canary Health Implanted Reporting Processor (CHIRP) System
Applicant
Canary Medical USA LLC
510(k) number
K220413
Product code
QPP  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-22
Date received
2022-02-14
Regulation
888.3600
Classification name
Implantable Post-surgical Kinematic Measurement Knee Device
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nora C.R. York
Address
2710 Loker Ave. W., Suite 350 Carlsbad CA US 92010 92010

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QPP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K234056canturio® se (Canturio Smart Extension)Canary Medical USA, LLC2024-04-24
K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC2023-03-24
DEN200064Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical, Inc.2021-08-27

Legacy Summary#

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FDA Review#

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