510(k) Report

Devices descending from K133556

27 later devices reach Virage Oct Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182182YUKON OCT Spinal SystemK2m20185—
+1K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+1K150918PASS OCT Spinal SystemMedicrea International SA201513—
+1K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K193129Yukon OCT Spinal SystemK2m, Inc.202001
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+2K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+2K161149PASS OCT Spinal SystemMedicrea International SA20160—
+2K160756PASS OCT Spinal SystemMedicrea International SA20160—
+2K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+3K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+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—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—