510(k) Report

Devices descending from K043405

712 later devices reach Nuvasive Coroent System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+1K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+1K051454Aleutian Spacer SystemK2m, LLC2005666—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K102315Staxx XDL SystemSpine Wave, Inc.20113—
+2K110843Aleutian Spacer SystemK2m, Inc.2011589—
+2K103666Lanx LateralLanx, Inc.2011238—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K082698Aleutian Ibf SystemK2m, Inc.2009662—
+2K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+2K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+2K063399Aleutian Spacer SystemK2m, Inc.2007663—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+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—
+3K141135Juliet LLSpineart2014146—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K131178Idys Lif CagesClariance201311—
+3K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K123388K7C SpacerK7, LLC20130—
+3K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K113138Aleutian SystemK2m, Inc.2012549—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K103169AleuttianK2m, Inc.2011572—
+3K101302Aleutian Ibf SystemK2m, Inc.2010595—
+4K261049Scala® TLSpineart SA20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243670Idys® LIFClariance20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.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—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+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—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—