510(k) Report

Devices descending from K063606

11 later devices reach Modification to Staxx FX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+1K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+2K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+2K181262SpineJack Expansion KitVexim SA20184—
+2K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+3K240084V-STRUT® Vertebral ImplantHyprevention20240—
+3K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+3K202393SpineJack Expansion KitStryker Corporation20203—
+4K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K223294SpineJack® Expansion KitStryker Instruments20221—
+6K250637VCFix Spinal SystemAmber Implants20250—