510(k) Report

Devices descending from K091813

719 later devices reach Intrepid Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+7K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+7K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K192993Scarlet AL-TSpineart20201—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K1803473d CageFims Co., Ltd.20190—
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—