510(k) Report

Devices descending from K042930

1,440 later devices reach Spacevision Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+1K051454Aleutian Spacer SystemK2m, LLC2005666—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K110843Aleutian Spacer SystemK2m, Inc.2011589—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K082698Aleutian Ibf SystemK2m, Inc.2009662—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K063399Aleutian Spacer SystemK2m, Inc.2007663—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K131178Idys Lif CagesClariance201311—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K123388K7C SpacerK7, LLC20130—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K113138Aleutian SystemK2m, Inc.2012549—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K103169AleuttianK2m, Inc.2011572—
+3K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+3K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+3K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+3K101302Aleutian Ibf SystemK2m, Inc.2010595—
+3K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+3K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+3K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+3K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+3K073502Vertebron VBR SystemVertebron, Inc.200812—
+4K261049Scala® TLSpineart SA20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243670Idys® LIFClariance20240—
+4K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+4K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K202380Born PT-LIF Cage HASpineworxx AG20210—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K181048Neo Cage System TMNeo Medical SA20191—