510(k) Report

Devices descending from K083389

633 later devices reach Coalition Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+3K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K263049SABER-C SystemElevation Spine20260—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+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—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—