510(k) Report

Devices descending from K212397

4 later devices reach StealthStation S8 Cranial v2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.20260—
+1K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav20250—
+1K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and…Stryker Corporation202312
+2K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho…Stryker Leibinger GmbH & Co KG20240—