Product code SAI

Device name

Ankle Fusion Cage

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3020

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset