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FDA Product Code

FDA Product Code SAI — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3020

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K242356 TIDAL Fusion Cage System Restor3D, Inc. 2025-03-24 Traditional PDF ↗
K230088 Ankle Truss System (ATS) 4Web Medical, Inc. 2024-03-21 Traditional PDF ↗

Product code SAI · Class II · Orthopedic. Data: openFDA.