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

Clearance record K162236

Ax Stand-Alone ALIF System · Innovasis, Inc. · decided 2017-04-20 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Statyx™AXT183020INNO Holdings, Inc.OVDM711AXT1830200