Product code KWJ
- Device name
- Prosthesis, Elbow, Hemi-, Humeral, Metal
- Medical specialty
- Orthopedic
- Device class
- 3
- Regulation number
- 888.3180
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
- Source
- FDA openFDA device classification dataset