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510(k) K220413

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System by Canary Medical USA, LLC — Product Code QPP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2022
Date Received
February 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Post-Surgical Kinematic Measurement Knee Device
Device Class
Class II
Regulation Number
888.3600
Review Panel
OR
Submission Type

An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery.

Other clearances by Canary Medical USA, LLC

  • K234056 — canturio® se (Canturio Smart Extension) (April 24, 2024)
  • K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor ( (March 24, 2023)

Other clearances for product code QPP

  • K234056 — canturio® se (Canturio Smart Extension) (April 24, 2024)
  • K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor ( (March 24, 2023)
  • DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) (August 27, 2021)