510(k) Report

Devices descending from K032476

753 later devices reach Nuvasive Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+1K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+1K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc.201574—
+1K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+1K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+1K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+2K261031Poseidon STSignus Medinzintechnik GmbH20260—
+2K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+2K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.20190—
+2K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+2K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+2K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568—
+2K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+2K142030STGC-LordoticCardinal Spine, LLC201558—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+3K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+3K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K103666Lanx LateralLanx, Inc.2011238—
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K230026SqualeImplanet, S.A.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K173893TrabisColigne AG20180—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141135Juliet LLSpineart2014146—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K133207Staxx (R) SystemSpine Wave, Inc.20131—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131178Idys Lif CagesClariance201311—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—