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U.S. Department of Health and Human Services

Product Classification
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Device intraoperative surgical angle measurement tool
Definition An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.
Physical State Accelerometer hardware, associated surgical instruments, and software to display angle measurements. The device does not include software that outputs any clinical interpretation of the data.
Technical Method Utilizes accelerometers to intraoperatively measure the angle orientation surgical instruments.
Target Area Lumbar spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQWL
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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