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

Clearance record K173115

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS · Globus Medical, Inc. · decided 2017-12-20 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
COALITION MIS1136.2013GLOBUS MEDICAL, INC.OVE00889095390001
COALITION MIS1136.2011GLOBUS MEDICAL, INC.OVE00889095389999