510(k) Report

Devices descending from K072317

625 later devices reach Modification to:TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173508Everest Spinal SystemK2m20189—
+7K173126Arisstos™ Spinal SystemIngenium Spine20171—
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K171321K2M Navigation InstrumentsK2m201711
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+7K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+7K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+7K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+7K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+7K142499Reline SystemNu Vasive, Incorporated201478—
+7K142381Xia 3 Spinal SystemStryker Corp.201483—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253249TriALTIS™ Spine SystemMedos International SARL20251—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K241258Ingenix Spinal SystemIngenium Spine20240—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K223558CUVIS-spineCurexo, Inc.20230—
+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—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—