510(k) Report

Devices descending from K221087

2 later devices reach Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231976StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc.20231—
+2K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.20250—