Product code ISY
- Device name
- Joint, Knee, External Limb Component
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3420
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101859 | REL-K ARTIFICAL LIMB PROSTHESIS | Rizzoli Ortopedica S.P.A. | 2010-10-13 |
Related GUDID Devices#
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|---|---|---|---|
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| 00195411458905 | Icon | COLLEGE PARK INDUSTRIES, INC. | 2025-05-28 |
| 00195411458837 | Icon | COLLEGE PARK INDUSTRIES, INC. | 2024-06-19 |
| 00841747186707 | Aura | COLLEGE PARK INDUSTRIES, INC. | 2024-06-19 |
| 00195411458868 | Icon | COLLEGE PARK INDUSTRIES, INC. | 2024-06-19 |
| 00195411458820 | Icon | COLLEGE PARK INDUSTRIES, INC. | 2024-06-19 |
| 00195411458844 | Icon | COLLEGE PARK INDUSTRIES, INC. | 2024-06-19 |
| 00195411458851 | Icon | COLLEGE PARK INDUSTRIES, INC. | 2024-06-19 |
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| 05690967596644 | Rheo Knee | OSSUR AMERICAS, INC. | 2018-05-16 |
| 05690967595418 | Rheo Knee | OSSUR AMERICAS, INC. | 2018-05-16 |
| 05690967566227 | Rheo Knee | OSSUR AMERICAS, INC. | 2018-05-16 |
| 05690967529864 | Rheo Knee | OSSUR AMERICAS, INC. | 2018-05-16 |