SAI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ankle Fusion Cage
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Medical specialty
- Orthopedic
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TIDAL Fusion Cage System (K242356) | Restor3D, Inc. | 2025-03-24 |
| Ankle Truss System (ATS) (K230088) | 4Web Medical, Inc. | 2024-03-21 |
Track SAI automatically
Every clearance here is in the API, with alerts when new ones post.