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Comparing FDA's UDI Database with FDA's 510k Database

FDA’s regulatory classification for Thoracolumbosacral pedicle screw system. Data from the 510k files seem like they would be accurate. Similar to UDI database, 510k database is based on input initially from companies. eSTAR system asks whether device is combination product. ....

Unique Device Identifier , Using Data From , Premarket Pathways , Combination Products Guidance , Medical Devices , Unpacking Averages , Star System , 10k Database , Di Database , Combination Product , Penfda Apis ,