FDA Product Code PBJ: Cranial Distraction System
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.
Leading manufacturers include KLS-Martin L.P..
6
Total
6
Cleared
193d
Avg days
2012
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Cranial Distraction System Devices (Product Code PBJ)
6 devices
About Product Code PBJ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PBJ since 2012, with 6 receiving FDA clearance (average review time: 193 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
PBJ devices are reviewed by the Neurology panel. Browse all Neurology devices →