# Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
> **Product code: QAD** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3023
## Classification
- **FDA Product Code:** QAD
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3023
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.  The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.

## Market data
- **Cleared 510(k) submissions:** 7
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QAD)
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