510(k) Report

Devices descending from K110543

808 later devices reach Crescent (R) Spinal System Titanium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K171312FortiCore®Nanovis, LLC20183—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170055CAPRI Corpectomy Cage SystemK2m201711—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—