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

Clearance record K132191

SP-FIX SPINOUS PROCESS FIXATION PLATE · Globus Medical, Inc. · decided 2013-11-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SP-FIX588.132GLOBUS MEDICAL, INC.KWP PEK00849044092370
SP-FIX588.126GLOBUS MEDICAL, INC.KWP PEK00849044092356
SP-FIX588.150GLOBUS MEDICAL, INC.KWP PEK00849044092431
SP-FIX588.138GLOBUS MEDICAL, INC.KWP PEK00849044092394
SP-FIX188.722GLOBUS MEDICAL, INC.KWP PEK00849044092080
SP-FIX588.144GLOBUS MEDICAL, INC.KWP PEK00849044092417
SP-FIX588.147GLOBUS MEDICAL, INC.KWP PEK00849044092424
SP-FIX188.026GLOBUS MEDICAL, INC.KWP PEK00849044091588
SP-FIX688.172GLOBUS MEDICAL, INC.LXH00849044092622
SP-FIX188.426GLOBUS MEDICAL, INC.KWP PEK00849044091885
SP-FIX188.326GLOBUS MEDICAL, INC.KWP PEK00849044091786
SP-FIX588.141GLOBUS MEDICAL, INC.KWP PEK00849044092400
SP-FIX588.135GLOBUS MEDICAL, INC.KWP PEK00849044092387
SP-FIX188.126GLOBUS MEDICAL, INC.KWP PEK00849044091687
SP-FIX688.226GLOBUS MEDICAL, INC.LXH00849044092639
SP-FIX588.155GLOBUS MEDICAL, INC.KWP PEK00849044092448
SP-FIX588.026GLOBUS MEDICAL, INC.KWP PEK00849044092257
SP-FIX588.129GLOBUS MEDICAL, INC.KWP PEK00849044092363
SP-FIX688.122GLOBUS MEDICAL, INC.LXH00849044092547