AI devices with FDA product code OLO — Orthopedic Stereotaxic Instrument
Product code OLO (“Orthopedic Stereotaxic Instrument” in openFDA) covers 10 devices on the FDA AI-enabled list, from 7 companies. Most are reviewed by the Neurology panel (10). The most recent decision was Stealth AXiS Surgical System with Stealth AXiS Spine clinical application on February 12, 2026.
10AI devices
7Companies
2018First decision
2026-02-12Latest decision
Trend: devices per year
20182023202420252026
Top companies
All 10 devices, newest first
- Stealth AXiS Surgical System with Stealth AXiS Spine clinical applicationMedtronic Navigation, Inc. · Neurology
- Mazor X System / Mazor X Stealth EditionMazor Robotics Ltd. · Neurology
- TMINI Miniature Robotic SystemTHINK Surgical, Inc. · Neurology
- OTS HipOrtoma AB · Neurology
- TMINI Miniature Robotic SystemTHINK Surgical, Inc. · Neurology
- ARVIS® ShoulderInsight Medical Systems, Inc. · Neurology
- Automatic RegistrationBrainlab AG · Neurology
- OTS HipOrtoma AB · Neurology
- Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG · Neurology
- NuVasive Pulse SystemNuVasive, Incorporated · Neurology