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

Clearance record K123270

POWEREASE SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2013-01-11 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
POWEREASE™ Instruments2342425MEDTRONIC SOFAMOR DANEK, INC.GWF HBE HWE00643169013100
POWEREASE™ Instruments2342426MEDTRONIC SOFAMOR DANEK, INC.GWF HBE HWE00643169013117