510(k) Report

Devices descending from K001066

768 later devices reach CD Horizon Eclipse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+9K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+9K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+9K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+9K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+9K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K222789VADER® Pedicle System, G21 CementIcotec AG202352
+10K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+10K180324Patriot Spinal Fixation SystemValorus Spine20180—
+11K232628VADER® Pedicle SystemIcotec AG20241—
+12K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—