510(k) Report

Devices descending from K121680

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K241258Ingenix Spinal SystemIngenium Spine20240—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—