# Prosthesis, Elbow, Hemi-, Humeral, Metal
> **Product code: KWJ** · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3180
## Classification
- **FDA Product Code:** KWJ
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 888.3180
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96

## 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=KWJ)
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