# Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
> **Product code: KTW** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3030
## Classification
- **FDA Product Code:** KTW
- **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
## Market data
- **Cleared 510(k) submissions:** 38
- **Registered establishments:** 50
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=KTW)
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