510(k) Report

Devices descending from K093434

7 later devices reach Vertex Reconstruction System and Vertex Select Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200896Solstice CCILife Spine, Inc.20200—