Device |
anterior staple as supplemental fixation for fusion |
Regulation Description |
Spinal intervertebral body fixation orthosis. |
Definition |
Anterior cervical device for supplemental fixation to support a fusion. |
Physical State |
This is a metalic staple that is implanted into two adjacent vertebral bodies. |
Technical Method |
The staple provides physical support while a fusion develops between vertebral bodies. |
Target Area |
This is intended for the anterior, cervical spinal column in skeletally mature patients. |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | PHQ |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
Submission Type |
510(k)
|
Regulation Number |
888.3060
|
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
|
Third Party Review |
Not Third Party Eligible |