510(k) Report

Devices descending from K082572

659 later devices reach Uss Iliosacral, Uss Polyaxial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132395LigapassMedicrea International201323—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K132287Jazz SystemHogan Lovells US LLP201315—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+3K121541Jazz SystemImplanet, S.A.201227—
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—