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510(k) K234056

canturio® se (Canturio Smart Extension) by Canary Medical USA, LLC — Product Code QPP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2024
Date Received
December 22, 2023
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

  • 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)

Other clearances for product code QPP

  • 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)
  • DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) (August 27, 2021)