510(k) Report

Devices descending from K012255

7 later devices reach Medtronic Sofamor Danek Cement Restrictor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051607Novaspine Cement Restrictor NSCRNovaspine, LLC20050—
+1K021719Fortitude Cement RestrictorSpinal Concepts, Inc.20026—
+2K060132Spinal Usa Cement Restrictor SystemSpinal USA20060—
+2K041583Peek Cement Restrictor X-BoxInnovasis, Inc.20040—
+2K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.20035—
+3K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp20050—
+3K052367Scient'x Cement RestrictorScient'X20051—