FDA product code OCJ

Spinal Channeling Instrument, Vertebroplasty

Orthopedic·Class 1·21 CFR 888.4540
US regulatory classifications
US Product Code (FDA)
OCJ
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 888.4540
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Spinal Channeling Instrument, Vertebroplasty is a medical device type in the Orthopedic 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.

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.