510(k) Report

Devices descending from K102293

869 later devices reach Caliber Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230026SqualeImplanet, S.A.20230—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+8K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+8K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+8K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+8K182477Cervical SpacerAdditive Implants, LLC201915—
+8K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+8K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+8K171312FortiCore®Nanovis, LLC20183—
+8K171140Matrixx SystemNexxt Spine, LLC2017145—
+8K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+8K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+8K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K170055CAPRI Corpectomy Cage SystemK2m201711—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162264Cascadia Interbody SystemK2m, Inc.2016169—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+9K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+9K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+9K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K210359Hexanium TLIFSpinevision, S.A.S.20211—
+9K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+9K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+9K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+9K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+9K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+9K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+9K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+9K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+9K172941CASCADIA Interbody SystemK2m201852—
+9K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+9K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+9K171704CAPRI Corpectomy Cage SystemK2m201710—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+10K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+10K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+10K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+10K223251Hexanium PLIFSpinevision, S.A.S.20220—
+10K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K202637F3D Corpectomy SystemCorelink, LLC20201—
+10K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+11K253545Vulcan Spinal SystemK2m, Inc.20260—
+11K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+11K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—