510(k) Report

Devices descending from K093058

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—