510(k) Report

Devices descending from K080537

958 later devices reach L-Varlock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K230026SqualeImplanet, S.A.20230—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+11K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+12K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—