SAI — Ankle Fusion Cage Class II
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.