510(k) Report

Devices descending from K021719

6 later devices reach Fortitude Cement Restrictor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060132Spinal Usa Cement Restrictor SystemSpinal USA20060—
+1K051607Novaspine Cement Restrictor NSCRNovaspine, LLC20050—
+1K041583Peek Cement Restrictor X-BoxInnovasis, Inc.20040—
+1K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.20035—
+2K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp20050—
+2K052367Scient'x Cement RestrictorScient'X20051—