510(k) Report

Devices descending from K083026

1,042 later devices reach Clydesdale Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+6K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—