NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

FDA 510(k)

FDA Class 2 ·Neurology

Stealth Autoguide System, Midas Rex Legend Depth Stop System

FDA 510(k)

FDA Class 2 ·Neurology

Visualase MRI-Guided Laser Ablation System (SW 3.4)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Visualase Thermal Therapy System

FDA 510(k)

FDA Class 2 ·Radiology

Fusion Compact Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

Synergy Cranial

FDA 510(k)

FDA Class 2 ·Neurology

StealthStation Cranial Software v1.3.0

FDA 510(k)

FDA Class 2 ·Neurology

StealthConnect Remote Viewing, Planning and Collaboration System

FDA 510(k)

FDA Class 2 ·Neurology

StealthStation Cranial Software, v3.1.5 (9735585)

FDA 510(k)

FDA Class 2 ·Neurology

Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

FDA 510(k)

FDA Class 2 ·Neurology

StealthStation S8 System Platforms and StealthStation Cranial Software

FDA 510(k)

FDA Class 2 ·Neurology

STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION

FDA 510(k)

FDA Class 2 ·Neurology

Stealthstation S8 Spine Software v1.3.0

FDA 510(k)

FDA Class 2 ·Neurology

Cranial Reducing Tubes

FDA 510(k)

FDA Class 2 ·Neurology

AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

StealthStationTM S8 ENT Software

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS

FDA 510(k)

FDA Class 2 ·Neurology

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

FDA 510(k)

FDA Class 2 ·Neurology

O-arm O2 Imaging System

FDA 510(k)

FDA Class 2 ·Radiology