510(k) Report

Devices descending from K071942

24 later devices reach Modification to Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+1K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+2K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200896Solstice CCILife Spine, Inc.20200—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—