510(k) Report

Devices descending from K130445

9 later devices reach Vault Alif System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+1K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+1K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+1K132596Proposed OptimusCustom Spine, Inc.201451
+2K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+2K160291Optimus ALIF SystemAmendia, Inc.20160—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—