510(k) Report

Devices descending from K083637

791 later devices reach Calix Spinal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K203254Lucent 3D Spinal SystemSpinal Elements, Inc.20218—
+4K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K192897icotec Cervical CageIcotec AG20201—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+4K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—