510(k) Report

Devices descending from K083637

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142328nvcNvision Biomedical Technologies, LLC20144—
+1K140066Infill CervicalPinnacle Spine Group, LLC20140—
+1K112036Calix PC Spinal Implant SystemX-Spine Systems, Inc.2011775—
+1K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+2K190380nvcNvision Biomedical Technologies, Inc.20193—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+2K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC20162—
+2K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+2K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.2014130—
+2K133653Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.2014286—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133192Mectalif TipeekMedacta International201416—
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+2K110632Lucent or Lucent MagnumSpinal Elements, Inc.20126941
+2K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K242303MOD-COrthomod, LLC20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+3K160528ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201623—
+3K160291Optimus ALIF SystemAmendia, Inc.20160—
+3K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+3K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.201523—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+3K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+3K122967LucentSpinal Elements, Inc.2013615—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K234150Lucent® XPSpinal Elements20240—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220902Navagio Lumbar CageKalitec Medical, LLC20220—