Device |
growing rod system |
Regulation Description |
Thoracolumbosacral pedicle screw system. |
Definition |
Stabilization or correction of spinal deformities without the use of fusion. |
Physical State |
Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories. |
Technical Method |
The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows. |
Target Area |
Pediatric spine. |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | PGM |
Premarket Review |
Office of Orthopedic Devices
(OHT6)
Spinal Devices
(DHT6B)
|
Submission Type |
510(k)
|
Regulation Number |
888.3070
|
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 |