510(k) Report

Devices descending from K081195

405 later devices reach Revere Uniplanar Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K113058Tiger Spine SystemCorelink, LLC201281—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—