510(k) Report

Devices descending from K161491

3 later devices reach Scopis Hybrid Navigation System EM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+1K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+1K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—