| 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 |
Office of Orthopedic Devices
(OHT6)
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 |
