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Implantable Post-Surgical Kinematic Measurement Knee Device

FDA product code QPP · 3 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3600
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-06-22 – 2024-04-24

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.

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