510(k) Report

Devices descending from K063399

663 later devices reach Aleutian Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110843Aleutian Spacer SystemK2m, Inc.2011589—
+1K082698Aleutian Ibf SystemK2m, Inc.2009662—
+2K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K160547Cascadia Interbody SystemK2m2016157—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K133614Aleutian Ibf SystemK2m, Inc.2014527—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131178Idys Lif CagesClariance201311—
+2K130699Aleutian Spinal SystemK2m, Inc.2013570—
+2K123388K7C SpacerK7, LLC20130—
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K113138Aleutian SystemK2m, Inc.2012549—
+2K112664Zavation Ibf SystemsZavation, LLC201137—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K103169AleuttianK2m, Inc.2011572—
+2K101302Aleutian Ibf SystemK2m, Inc.2010595—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K261049Scala® TLSpineart SA20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K243670Idys® LIFClariance20240—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K202032Idys LLIF 3DTiClariance, Sas20210—
+3K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+3K202380Born PT-LIF Cage HASpineworxx AG20210—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K183259Idys™ TLIF TiVacClariance, Sas20191—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K153621Juliet® TiSpineart2016751
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—