510(k) Report

Devices descending from K052638

20 later devices reach Abbott Spine, Inc. Spinnaker System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152872K2M Fenestrated Tap SystemK2m201602
+1K060148Ebi Vertebroplasty SystemsEbi, L.P.200618—
+2K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+2K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+3K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+3K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+3K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+4K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+4K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+4K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+5K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+5K181262SpineJack Expansion KitVexim SA20184—
+5K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+5K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20110—
+6K240084V-STRUT® Vertebral ImplantHyprevention20240—
+6K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+6K202393SpineJack Expansion KitStryker Corporation20203—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+9K250637VCFix Spinal SystemAmber Implants20250—