510(k) Report

Devices descending from K083389

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K250560BEE HANGMedical GmbH20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K172065Scarlet AC-TSpineart20172—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.201523—