Ankle Fusion Cage

SAI · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3020

Classification

FDA Product Code: SAI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3020
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown