OCJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Spinal Channeling Instrument, Vertebroplasty

Device class

Class I (low risk)

Regulation

21 CFR 888.4540

Medical specialty

Orthopedic

FDA 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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