FDA product code NOX

Filler, Bone Void, Synthetic Peptide

Unknown·Class 3·21 CFR ·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
NOX
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not 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.

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About this record

Filler, Bone Void, Synthetic Peptide is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.