Device |
intraoperative orthopedic strain sensor |
Regulation Description |
Intraoperative orthopedic strain sensor. |
Definition |
A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making. |
Physical State |
The device is a strain gauge and associated reader and display instruments. |
Technical Method |
The sensor measures strain on the implant via a strain gauge and provides the output reading on a display. |
Target Area |
Bone |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | QFP |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
Submission Type |
510(k)
|
Regulation Number |
888.3090
|
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 |