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..
1
Total
1
Cleared
299d
Avg days
2023
Since
List of Cranial Distraction System devices cleared through 510(k)
1 devices
How to use this database
This page lists all FDA 510(k) submissions for Cranial Distraction System devices (product code PBJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Neurology FDA review panel. Browse all Neurology devices →