510(k) Report

Devices descending from K030500

11 later devices reach Oria Zenith through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+2K243369Cervical Plating SystemLife Spine, Inc.20240—
+2K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+2K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+3K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+3K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+3K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—