510(k) Report

Devices descending from K003709

1,714 later devices reach Surgical Dynamics Mesh Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K131178Idys Lif CagesClariance201311—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K123388K7C SpacerK7, LLC20130—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122444Cervical CageEisertech, LLC201222—
+3K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K111294Santorini Spinal SystemK2m, Inc.201218—
+3K113138Aleutian SystemK2m, Inc.2012549—
+3K112664Zavation Ibf SystemsZavation, LLC201137—
+3K113348Cougar SystemJohnson & Johnson2011591—
+3K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+3K103666Lanx LateralLanx, Inc.2011238—
+3K103169AleuttianK2m, Inc.2011572—
+3K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+3K102738Lanx Fusion SystemLanx, LLC20113281
+3K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+3K101302Aleutian Ibf SystemK2m, Inc.2010595—
+3K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+3K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+3K090566Pathway AvidCustom Spine, Inc.2009639—
+3K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+3K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009932—
+3K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K080568X-Mesh Expandable Cage SystemDepuy Spine, Inc.2008615—
+3K080281PathwayCustom Spine, Inc.2008188—
+3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+3K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+3K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+3K052670Staxx XD SystemSpine Wave, Inc.20068—
+3K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+3K053080Graftcage AcxOsteotech, Inc.20050—
+3K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular200521—
+3K052746Concorde VBR Spinal SystemDepuy Spine, Inc.20051,149—
+3K041939Blackstone Peek Vertebral Body Replacement System Lordotic Lateral SpacersBlackstone Medical, Inc.2004718—
+4K261049Scala® TLSpineart SA20260—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243670Idys® LIFClariance20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K202380Born PT-LIF Cage HASpineworxx AG20210—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+4K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—