510(k) Report

Devices descending from K031837

5 later devices reach Modification to Fortitude Cement Restrictor through their predicates, nearest generation first.

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