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U.S. Department of Health and Human Services

Product Classification

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Device electronic depth gauge
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.
Physical State May have components of metal and plastic, and includes a battery or power source, an LCD or other display, and software and/or firmware
Technical Method Uses a mechanical sliding probe, in conjunction with hardware that creates a variable voltage input based on probe position and software, to display digitally a measured depth
Target Area Bone or tissue sites where tunnels or steps exist, or drilling or cutting has occurred
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOOL
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible