510(k) Report

Devices descending from K982990

776 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—