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

Clearance record K160697

Gibralt® Spine System and Gibralt® Occipital Spine System · Exactech, Inc. · decided 2016-06-28 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Gibralt05-004-11-2636Choice Spine, LPKWP NKG00840996169936
Gibralt05-004-11-2230Choice Spine, LPKWP NKG00840996169929
Gibralt05-004-11-3848Choice Spine, LPKWP NKG00840996169950
Gibralt05-004-09-3848Choice Spine, LPKWP NKG00840996170000
Gibralt05-004-09-4452Choice Spine, LPKWP NKG00840996170017
Gibralt05-004-09-2230Choice Spine, LPKWP NKG00840996169974
Gibralt05-004-09-2636Choice Spine, LPKWP NKG00840996169981
Gibralt05-004-11-4452Choice Spine, LPKWP NKG00840996169967
Gibralt05-004-09-3242Choice Spine, LPKWP NKG00840996169998
Gibralt05-004-11-3242Choice Spine, LPKWP NKG00840996169943