510(k) Report

Devices descending from K123656

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+1K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+1K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+1K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+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—
+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—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K233366SYMPHONY OCT SystemMedos International SARL20230—
+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
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+4K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—