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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. ....
FDA's 510k database has frustrations. Bradley Merrill Thompson downloaded the data from that database and created his own search engine. Global Unique Device Identification Database is comprised of raw data entered by manufacturers without FDA review and FDA 501k is reviewed. ....