NUD

Vertebroplasty Compound, Calcium Based

Product code

NUD

Device name

Vertebroplasty Compound, Calcium Based

Device class

Class 2

21 CFR

21 CFR 888.3027

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

FDA classification definition

THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.

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