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
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K171425Concorde LiftMedos International SARL201782
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+7K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+7K152304Tritanium PL CageStryker20154481
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K140529Everest Spinal SystemK2m, LLC201431—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+7K132559Monument SpacersGlobus Medical, Inc.2013166—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+7K130445Vault Alif SystemSpinal USA20139—
+7K130194Acculif XL CageCoalign Innovations, Inc.20131—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+7K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302