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Ankle Fusion Cage

FDA product code SAI · 2 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3020
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-03-21 – 2025-03-24

Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use.

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