DeviceClearance

Product code OCJ— Orthopedic

BENVENUE VCF OSTEO COIL SYSTEM

Classification name
Spinal Channeling Instrument, Vertebroplasty
Device class
Class 1
Regulation
21 CFR 888.4540
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.”

— U.S. Food and Drug Administration, device classification record for product code OCJ under 21 CFR 888.4540, via openFDA

Market context for product code OCJ

FDA has cleared 1 device under product code OCJ, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OCJ

Recent clearances under product code OCJ

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