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

Clearance record K181328

T2 STRATOSPHERE™ Expandable Corpectomy System · Medtronic Sofamor Danek USA, Inc. · decided 2018-09-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
T2 STRATOSPHERE™ Expandable Corpectomy System436013EMEDTRONIC SOFAMOR DANEK, INC.MQP00763000856281