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510(k) DEN200064

Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System by Canary Medical, Inc. — Product Code QPP

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 27, 2021
Date Received
October 19, 2020
Clearance Type
Direct
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 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)
  • K220413 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor ( (June 22, 2022)