Device |
sacroiliac joint fixation |
Regulation Description |
Smooth or threaded metallic bone fixation fastener. |
Definition |
sacroiliac joint fusion |
Physical State |
may be used with bone graft, should not be used with bone cement |
Technical Method |
bridges both sides of the joint, preventing motion |
Target Area |
sacroiliac joint |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | OUR |
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 |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |