510(k) Report

Devices descending from K081730

705 later devices reach Novel Cervical Spinal Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K130853Idys (TM) CClariance20132—
+3K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K242303MOD-COrthomod, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K230026SqualeImplanet, S.A.20230—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043