Ankle Fusion Cage
An ankle fusion cage is an orthopedic implant intended for use as an accessory to a tibiotalocalcaneal intramedullary rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty; it is not intended for standalone use. It is classified as FDA Class II (510(k) required) under regulation 888.3020 in the Orthopedic specialty, with product code SAI. The device is flagged as an implant, reflecting its permanent placement in the body, though it is not life-sustaining.
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Basic Information
- Product Code
- SAI
- Device Class
- FDA class 2
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.