510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K230614Cortium™Ulrich Medical USA20230—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K191217Jazz PFImplanet, S.A.20190—
+7K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+7K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+7K162575Z-LINKPC SystemZavation, LLC20173—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+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
+7K141284Caspian Spinal SystemK2m, Inc.20140—
+7K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—