510(k) Report

Devices descending from K001066

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172021LigaPASSMedicrea International SA201711—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162575Z-LINKPC SystemZavation, LLC20173—
+7K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K150918PASS OCT Spinal SystemMedicrea International SA201513—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+7K142798PASS LP Spinal SystemMedicrea International SA201584—
+7K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+7K150049PASS LP Spinal SystemMedicrea International20150—
+7K141398Pass LP Spinal SystemMedicrea International SA2015101
+7K140738Pass LP Spinal SystemMedicrea International201447—
+7K141284Caspian Spinal SystemK2m, Inc.20140—
+7K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K132574Pass LP Spinal SystemMedicrea International20130—
+7K132575Pass LP Spinal SystemMedicrea International20130—
+7K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+7K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+7K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+7K120998Solstice Cross ConnectorLife Spine20121—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+8K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA20222—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K190418NuVasive® VersaTie® SystemNu Vasive, Incorporated20190—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K173506LigaPASSMedicrea International SA20189—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+8K160640PASS XS Spinal SystemMedicrea International SA20160—
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161627PASS LP Spinal SystemMedicrea International SA20167—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K153413PASS LP Spinal SystemMedicrea International SA20160—