510(k) Report

Devices descending from K031702

245 later devices reach Reflex Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+6K190053SECULOK™ ACP SystemU&I Corporation20191—
+6K182055SECULOK™ ACP SystemU&I Corporation20182—
+6K173521SeaSpine Cabo ACP (Anterior Cervical Plate) SystemSeaSpine Orthopedics Corporation201815—
+6K171112Trifore (tm) Cervical Plating SystemNeurostructures, Inc.20171—
+6K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+6K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+6K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+7K261049Scala® TLSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220147Aspiron S ACP SystemU&I Corporation20220—
+7K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+7K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K202064Admiral ACP SystemSeaSpine Orthopedics Corporation202014—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K254182AsterOsteonic Co., Ltd.20260—
+8K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—