510(k) Report

Devices descending from K041939

718 later devices reach Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223326Axiom PSR SystemRestor3D202301
+7K230583Tryptik TiSpineart SA20231—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K200429BEE CagesNGMedical GmbH202111—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K192993Scarlet AL-TSpineart20201—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+7K1803473d CageFims Co., Ltd.20190—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+7K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+7K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—