510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K200919Idys ALIF 3DTiClariance20210—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K200429BEE CagesNGMedical GmbH202111—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—