510(k) Report

Devices descending from K142591

212 later devices reach CD HORIZON Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—