510(k) Report

Devices descending from K043566

726 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+9K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+9K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+9K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+9K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+9K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K1803473d CageFims Co., Ltd.20190—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+9K190680Favo S-TlifSilony Medical GmbH20190—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+9K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+10K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+10K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K261067BEE PLIF CageNGMedical GmbH20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+10K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+10K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+10K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+10K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+10K223418DeGen Impulse AM™ SystemDegen Medical20236—
+10K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+10K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K212358Romero Cervical CageSpineup, Inc.20226—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K211413BEE PLIF CageNGMedical GmbH20211—
+10K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+10K210728CONDUIT InstrumentsMedos International SARL20215—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—