OCJ

Spinal Channeling Instrument, Vertebroplasty

Product code

OCJ

Device name

Spinal Channeling Instrument, Vertebroplasty

Device class

Class 1

21 CFR

21 CFR 888.4540

Medical specialty

Orthopedic

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).