510(k) Report

Devices descending from K101923

609 later devices reach Concorde Curve System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+1K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+1K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+1K113348Cougar SystemJohnson & Johnson2011591—
+1K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+1K103743Concorde Curve SystemJohnson & Johnson20110—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181397DualXInnovasive, Inc.201815—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K230583Tryptik TiSpineart SA20231—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K192897icotec Cervical CageIcotec AG20201—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K261049Scala® TLSpineart SA20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—