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
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K200919Idys ALIF 3DTiClariance20210—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K200312Tryptik TiSpineart20202—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K193174Keos Lumbar IBFDKeos20190—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K1803473d CageFims Co., Ltd.20190—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+5K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—