NOX · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NOX
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
Definition
The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.