Product code NOX

Device name

Filler, Bone Void, Synthetic Peptide

Medical specialty

Unknown

Device class

3

Review panel

OR

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset