Device |
bone indentation device |
Regulation Description |
Bone indentation device. |
Definition |
A bone indentation device is a device that measures resistance to indentation in bone. |
Physical State |
Main device is a hand-held reusable stylus with single-use patient-contacting tip. Device includes electronics, laptop, and plastic resins. |
Technical Method |
The devices makes a puncture wound through skin and periosteum, and makes multiple indentations directly into the tibia. |
Target Area |
Mid-point on the left or right anterior tibia. |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | QGQ |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Restorative, Repair and Trauma Devices
(DHT6C)
|
Submission Type |
510(k)
|
Regulation Number |
888.1600
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |