Device |
growing rod system- magnetic actuation |
Definition |
Stabilization or correction of spinal deformities without the use of fusion, using non-invasive methods to adjust the spinal rod. |
Physical State |
Metalllic rods, monoaxial or polyaxial bone screws, hooks, magnetic remote control, and other related accessories. |
Technical Method |
The system of distracting rods and fixation elements (screws, hooks, etc.) provides stabilization of severe spinal abnormalities and distraction of the rod as the child grows, via magnetic actuation. |
Target Area |
Pediatric spine |
Regulation Medical Specialty |
Orthopedic |
Review Panel |
Orthopedic |
Product Code | PGN |
Premarket Review |
Spinal Devices
(DHT6B)
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
|
Third Party Review |
Not Third Party Eligible |
|
|