Product code OOL

Device name

Electronic Depth Gauge

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3030

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset