510(k) Report

Devices descending from K201189

15 later devices reach Stealthstation S8 Spine Software v1.3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+1K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+1K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+1K251282StealthStation S8 Spine SoftwareMedtronic Navigation, Inc.20252—
+1K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+1K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+1K213034SpineAR SNAPSurgical Theater, Inc.20222—
+1K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+2K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+2K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+2K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+2K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+2K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+2K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.202411
+3K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.20250—