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 Code | OOL |
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 Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |