510(k) Report

Devices descending from K211238

2 later devices reach SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223294SpineJack® Expansion KitStryker Instruments20221—
+2K250637VCFix Spinal SystemAmber Implants20250—