Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3045
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.