510(k) Report

Devices descending from K053101

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240699SCARLET® AC-TiSpineart SA20240—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223326Axiom PSR SystemRestor3D202301
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+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—
+8K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001