Device |
intraoperative surgical angle measurement tool |
Definition |
An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy. |
Physical State |
Accelerometer hardware, associated surgical instruments, and software to display angle measurements. The device does not include software that outputs any clinical interpretation of the data. |
Technical Method |
Utilizes accelerometers to intraoperatively measure the angle orientation surgical instruments. |
Target Area |
Lumbar spine |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | QWL |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
888.4560
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |