← FDA Medical Device Classifications
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
KRO · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3510
Classification
- FDA Product Code
KRO- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 888.3510
- 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
- 86
- Registered establishments
- 136
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown