QCG — Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions Class N

FDA Device Classification

FDA product code QCG covers "Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions", a Class N medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
QCG
Device Class
Class N
Regulation Number
Submission Type
Review Panel
OR
Medical Specialty
Unknown
Implant
Yes

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.