SAI — Ankle Fusion Cage Class II
FDA product code SAI covers "Ankle Fusion Cage", a Class II medical device regulated under 21 CFR 888.3020. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SAI
- Device Class
- Class II
- Regulation Number
- 888.3020
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
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.