Product code OCJ

Device name

Spinal Channeling Instrument, Vertebroplasty

Medical specialty

Orthopedic

Device class

1

Regulation number

888.4540

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset