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Cranial Distraction System

FDA product code PBJ · 5 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5330
Review panel
NE
Implant
Yes
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2012-08-22 – 2023-11-21

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.

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