510(k) Report

Devices descending from K961633

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+7K150417Astra Spine SystemSpinecraft, LLC201521—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K190751Connector SystemOrthofix, Inc.20193—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K162786PASS LP Spinal SystemMedicrea International SA20176—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+9K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+9K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+9K182240PASS LP Spinal SystemMedicrea International SA20182—
+9K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+9K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K231658VEOS Spinal Fixation SystemSpineway20230—
+10K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+10K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+10K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+10K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+10K190376PASS LP Spinal SystemMedicrea International SA201915
+11K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+11K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+11K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+12K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+12K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+13K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—