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
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192117Small VBR™Ulrich GmbH & Co. KG20196—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171312FortiCore®Nanovis, LLC20183—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172756Varian cageMedyssey USA, Inc.20171—
+4K173148ACIFColigne AG20171—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172065Scarlet AC-TSpineart20172—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+4K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+4K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160631Keos Lumbar IBFDKeos20161—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153621Juliet® TiSpineart2016751
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153400ProLift Expandable SystemLife Spine, Inc.201672—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—