510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K072465Niko Corpectomy SpacerGlobus Medical, Inc.2007327—
+3K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+3K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656—
+3K061380Retain Radiolucent SpacerGlobus Medical, Inc.20060—
+3K060916Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC20061—
+3K060665Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc.2006274—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+3K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+3K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005829—
+3K052384Lanx VBR SystemLanx, LLC2005455—
+3K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005134—
+3K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology20051,571—
+3K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+3K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+3K041939Blackstone Peek Vertebral Body Replacement System Lordotic Lateral SpacersBlackstone Medical, Inc.2004718—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K250560BEE HANGMedical GmbH20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171140Matrixx SystemNexxt Spine, LLC2017145—