# Accessory, System, External Fixator, Containing Antimicrobial Agent
> **Product code: NJA** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3040
## Classification
- **FDA Product Code:** NJA
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3040
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones.  The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.

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