FDA product code PBJ

Cranial Distraction System

Neurology·Class 2·21 CFR 882.5330·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
PBJ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5330
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not Eligible
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.

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About this record

Cranial Distraction System is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.