Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Cement, Bone, Vertebroplasty (NDN) (2) Injector, Vertebroplasty (Does Not Contain Cement) (OAR) (1) Mixer, Cement, For Clinical Use (JDZ) (1)