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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implantable post-surgical kinematic measurement knee device
Definition 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.
Product CodeQPP
Regulation Number 888.3600
Device Class 2


Premarket Reviews
ManufacturerDecision
CANARY MEDICAL USA LLC
  SUBSTANTIALLY EQUIVALENT 2
CANARY MEDICAL, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Transmit Record 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 2 2

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