510(k) Report

Devices descending from K100788

374 later devices reach Cocr Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+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—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K193129Yukon OCT Spinal SystemK2m, Inc.202001
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+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—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—