510(k) Report

Devices descending from K151885

41 later devices reach SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+1K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+1K192013VERTICALE® Cervical SystemSilony Medical GmbH20202—
+1K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+1K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL20199—
+1K181949SYMPHONY™ OCT SystemMedos International SARL201810—
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+1K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+1K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+1K150474NuVasive VuePoint II OCT SystemNu Vasive, Incorporated201526—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+2K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+2K233366SYMPHONY OCT SystemMedos International SARL20230—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K192014SYPMHONY™ OCT SystemMedos International SARL20203—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+2K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+2K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K153336VuePoint OCT SystemNu Vasive, Incorporated20162—
+3K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+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—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+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—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—