510(k) Report

Devices descending from K160697

5 later devices reach Gibralt® Spine System and Gibralt® Occipital Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220658COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH20220—
+1K192354Innovasis Gibralt Spine SystemInnovasis, Inc.20190—
+1K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+1K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+2K200896Solstice CCILife Spine, Inc.20200—