Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions
QCG · Not classified · Unknown
Classification
FDA Product Code
QCG
Device class
Not classified
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Intended to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure. These defects may be surgically created from traumatic injury to the bone including bone marrow lesions.