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

Clearance record K140079

SILEX SACROILIAC JOINT FUSION SYSTEM · X-Spine Systems, Inc. · decided 2014-03-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Silex Sacroiliac Joint Fusion SystemC079-0263Xtant Medical Holdings, Inc.FZXM697C07902631