HBX — Instrument, Cranioplasty Material Forming Class I

FDA Device Classification

FDA product code HBX covers "Instrument, Cranioplasty Material Forming", a Class I medical device regulated under 21 CFR 882.4500. Submissions are reviewed by the Neurology panel.

Classification Details

Product Code
HBX
Device Class
Class I
Regulation Number
882.4500
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No