OAR

Injector, Vertebroplasty (Does Not Contain Cement)

Product code

OAR

Device name

Injector, Vertebroplasty (Does Not Contain Cement)

Device class

Class 1

21 CFR

21 CFR 888.4200

Medical specialty

Orthopedic

Marketing pathway

510(K) Exempt

510(k) clearances (last 3 years)

1

FDA classification definition

Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

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