Device |
cranial distraction system |
Regulation Description |
Preformed nonalterable cranioplasty plate. |
Definition |
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments. |
Physical State |
May include: distractors, distraction plates, spacers, screws and instrumentation |
Technical Method |
Bone segments are attached to the plate with screws to prevent movement of the segments. |
Target Area |
Cranium, skull |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | PBJ |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.5330
|
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? |
Yes
|
Third Party Review |
Not Third Party Eligible |