OOL

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Electronic Depth Gauge

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3030

Medical specialty

Orthopedic

FDA 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.

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