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
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+8K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+8K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+8K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+8K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K182349Concorde LiftMedos International SARL20190—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K173537Concorde Lift™Medos International SARL20181—
+8K173508Everest Spinal SystemK2m20189—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K162262Tritanium® PL CageStryker2016132—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+8K160955Tritanium® PL CageStryker2016178—
+8K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K151727Everest Spinal SystemK2m, Inc.201511—
+8K142360Everest Spinal SystemK2m, Inc.201522—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+8K141147Range Spinal SystemK2m, Inc.20141—
+8K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+8K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+8K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+8K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241895Cannulated PsiFGuardSpineguard20240—
+9K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+9K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—