# Filler, Bone Void, Synthetic Peptide
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NOX)
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