Spinal Channeling Instrument, Vertebroplasty

What Is It?

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.

What Is FDA Product Code OCJ?

Spinal Channeling Instrument, Vertebroplasty is FDA product code OCJ, Class 1, 21 CFR 888.4540.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2011. None was by a company in China. The root cause the FDA records most often is Packaging process control (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.