510(k) Report

Devices descending from K060148

18 later devices reach Ebi Vertebroplasty Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+1K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+2K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+2K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+2K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+3K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+3K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+3K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+4K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+4K181262SpineJack Expansion KitVexim SA20184—
+4K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+4K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20110—
+5K240084V-STRUT® Vertebral ImplantHyprevention20240—
+5K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+5K202393SpineJack Expansion KitStryker Corporation20203—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+8K250637VCFix Spinal SystemAmber Implants20250—