| Device |
sacroiliac joint guidewire placement device |
| Regulation Description |
Smooth or threaded metallic bone fixation fastener. |
| Definition |
A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint. |
| Physical State |
A sacroiliac joint guidewire placement device is made of a needle comprised of a metallic material to measure electric conductivity, along with a user interface/control unit handpiece. |
| Technical Method |
This device consists of both a software and hardware component. The hardware sends out electrical current and measures electrical conductivity. The software component produces an alert based on tissue impedance at the tip of the probe. |
| Target Area |
Sacroiliac joint. |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | SCY |
|---|
| Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3040
|
|---|
| 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 |
