510(k) Report

Devices descending from K032891

13 later devices reach TRANS1 Trans-Sacral Spinal Access and Preparation Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113352Transcorp Spinal Access SystemTranscorp, Inc.20120—
+1K081240Tiger Discectomy DeviceSpinal Devices, LLC20090—
+1K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+2K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+3K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+3K181262SpineJack Expansion KitVexim SA20184—
+3K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+4K240084V-STRUT® Vertebral ImplantHyprevention20240—
+4K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+4K202393SpineJack Expansion KitStryker Corporation20203—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+7K250637VCFix Spinal SystemAmber Implants20250—