DeviceClearance

Product code PBJ— Neurology

CranioXpand

Classification name
Cranial Distraction System
Device class
Class 2
Regulation
21 CFR 882.5330
Advisory panel
Neurology
Total cleared
6
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PBJ under 21 CFR 882.5330, via openFDA

Market context for product code PBJ

FDA has cleared 6 devices under product code PBJ between 2012 and 2023, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PBJ

Recent clearances under product code PBJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.