510(k) Report

Devices descending from K121191

23 later devices reach Vertex Rcconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123906Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201322—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—