510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+8K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+8K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+8K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+8K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+8K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+8K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+8K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+8K153400ProLift Expandable SystemLife Spine, Inc.201672—
+8K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+8K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+8K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+8K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K152304Tritanium PL CageStryker20154481
+8K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K143479Bluefin Interbody SystemTides Medical20152—
+8K151727Everest Spinal SystemK2m, Inc.201511—
+8K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+8K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+8K142360Everest Spinal SystemK2m, Inc.201522—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+8K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+8K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+8K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+8K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+8K141147Range Spinal SystemK2m, Inc.20141—
+8K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+8K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+8K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+8K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K130194Acculif XL CageCoalign Innovations, Inc.20131—
+8K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+8K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+8K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260660SABER-C SystemElevation Spine20261—
+9K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+9K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+9K250540SABER-C SystemElevation Spine20252—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241895Cannulated PsiFGuardSpineguard20240—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+9K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K240715Idys® C ZP 3DTiClariance20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—