510(k) Report

Devices descending from K110733

481 later devices reach Daytona Anterior Cervical Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230026SqualeImplanet, S.A.20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K182608Oyster ACIF CageSilony Medical GmbH20190—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K263049SABER-C SystemElevation Spine20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—