510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+5K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+5K113346Neon SystemUlrich GmbH & Co. KG20121—
+5K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+5K112388Lanx Cervical SALanx, Inc.201126—
+5K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K230614Cortium™Ulrich Medical USA20230—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K223326Axiom PSR SystemRestor3D202301
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—