OIS

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Product code

OIS

Device name

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Device class

Class 2

21 CFR

21 CFR 888.3045

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.

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