510(k) Report

Devices descending from K040483

52 later devices reach Equestra Fluid Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070351Space 360 Delivery SystemDfine, Inc.20071—
+1K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+1K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+1K060148Ebi Vertebroplasty SystemsEbi, L.P.200618—
+1K043602Quadrant Retractor SystemMedtronic Sofamor Danek200529—
+1K043568Equestra Fluid Delivery SystemMedtronic Sofamor Danek20050—
+2K151104Otelo LLSpineart20160—
+2K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+2K113273Spotlight Access SystemJohnson & Johnson20120—
+2K090986Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/…Dfine, Inc.20090—
+2K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc.20090—
+2K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+2K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+2K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.200614—
+2K060973Vycor Surgical Access SystemsVycor Medical, LLC200610Class I
+3K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS…Vycor Medical, Inc.20210—
+3K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+3K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+3K120691Brain PortNico Corporation201282
+3K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+3K093062Vertos Medical Mild Device KitX-Sten Corp.201013—
+4K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.20243—
+4K212636CORUS Spinal System-XProvidence Medical Technology, Inc.20215—
+4K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+4K182211Aurora Surgiscope SystemRebound Therapeutics Corporation20194—
+4K181262SpineJack Expansion KitVexim SA20184—
+4K180876DTRAX Spinal SystemProvidence Medical Technology, Inc.20187—
+4K150378NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookNico Corporation20152—
+4K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+4K122662Vertiflex Direct Decompression SystemVertiflex, Inc.20120—
+4K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20110—
+5K253523Freedom DS™ Decompression SystemSpinal Simplicity20260—
+5K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+5K240084V-STRUT® Vertebral ImplantHyprevention20240—
+5K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+5K202393SpineJack Expansion KitStryker Corporation20203—
+5K191861Aurora Surgiscope SystemRebound Therapeutics20193—
+5K190201CORUS Spinal SystemProvidence Medical Technology, Inc.20196—
+5K172433NICO BrainPathNico Corporation20171—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC20260—
+6K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)Rebound Therapeutics202021
+6K202072MindsEye Expandable PortMinnetronix Neuro, Inc.20200—
+7K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+7K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences Corporation20250—
+7K232618Aurora Surgiscope SystemRebound Therapeutics Corporation202301
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+8K250637VCFix Spinal SystemAmber Implants20250—