510(k) Report

Devices descending from K110216

4 later devices reach Expedium System, Viper System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+1K120928Synthes Matrix SystemSynthes Spine20120—
+2K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—