510(k) Report

Devices descending from K152338

34 later devices reach VERTEX (r) Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+1K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+1K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+1K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+1K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+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—
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K233366SYMPHONY OCT SystemMedos International SARL20230—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—