510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+7K141850Flospine Pedicle Screw SystemFlospine20140—
+7K142381Xia 3 Spinal SystemStryker Corp.201483—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+7K141044M.U.S.T. ExtensionMedacta International201416—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+7K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+7K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+7K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+7K132878M.U.S.T. ExtensionMedacta International201328—
+7K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K131784Range Spinal SystemK2m, Inc.201334—
+7K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+7K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+7K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+7K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+8K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241258Ingenix Spinal SystemIngenium Spine20240—
+8K240392JAZZ Spinal SystemImplanet20241—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—