510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NOXClass III

Filler, Bone Void, Synthetic Peptide

Unknown
FDA source (opens on fda.gov)

NOX is the FDA product code for Filler, Bone Void, Synthetic Peptide, a class III device type. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 4 recalls.

Classification record

Product code
NOX
Device name
Filler, Bone Void, Synthetic Peptide
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
4

Companies listing this code with FDA

Companies whose registered establishments list this code