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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record P050053

Device name not on record · Medtronic, Inc. · decided 2010-01-20 (APPR)

FDA 510(k) database ↗

Devices

BrandModelCompanyProduct codesPrimary DI
INFUSE® Bone Graft7510050MEDTRONIC SOFAMOR DANEK, INC.NEK NPZ00613994239518
INFUSE® Bone Graft7510100MEDTRONIC SOFAMOR DANEK, INC.NEK NPZ00613994239525