# Internal Hinged Elbow Fixator
> **Product code: OZI** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3030
## Classification
- **FDA Product Code:** OZI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3030
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint.  The device is intended to be removed once stability is achieved.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OZI)
---
*AI Analytics · CC0 1.0*