510(k) Report

Devices descending from K010530

1,764 later devices reach Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+8K250560BEE HANGMedical GmbH20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+8K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K193174Keos Lumbar IBFDKeos20190—
+8K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192117Small VBR™Ulrich GmbH & Co. KG20196—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+8K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+8K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+8K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+8K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+8K141896Coroent SystemNu Vasive, Incorporated2014480—
+8K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+8K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+8K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+8K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+8K133967Interbody Cage SystemAurora Spine2014227—
+8K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+8K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+8K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+8K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—