← FDA Medical Device Classifications
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
KWR · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3640
Classification
- FDA Product Code
KWR- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 888.3640
- 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 50711 on 9/27/96
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown