510(k) Report

Devices descending from K201175

8 later devices reach StealthStation Cranial Software v1.3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213989Cranial EM SystemBrainlab AG20221—
+1K203639StealthStation Cranial Software v1.3.2Medtronic Navigation, Inc.20215—
+2K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+2K212397StealthStation S8 Cranial v2.0Medtronic Navigation20214Class I
+3K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+3K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+3K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+4K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—