PBJ · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5330
Classification
FDA Product Code
PBJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5330
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.