10 devices · 7 companies · 2018 to 2026
Product code OLO: Orthopedic Stereotaxic Instrument
10 devices under product code OLO, 2018 to 2026, from 7 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 10 here), the regulation, and MAUDE report counts by product code.
Orthopedic Stereotaxic Instrument. 21 CFR 882.4560, Class II. Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW. MAUDE held 20,865 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Stealth AXiS Surgical System with Stealth AXiS SK253381 · 510(k) | Medtronic Navigation, Inc. | Neurology | database entry | |
| Mazor X System / Mazor X Stealth EditionK251316 · 510(k) | Mazor Robotics Ltd. | Neurology | database entry | |
| TMINI Miniature Robotic SystemK250877 · 510(k) | THINK Surgical, Inc. | Neurology | database entry | |
| OTS HipK250086 · 510(k) | Ortoma AB | Neurology | database entry | |
| TMINI Miniature Robotic SystemK243481 · 510(k) | THINK Surgical, Inc. | Neurology | database entry | |
| ARVIS ShoulderK240062 · 510(k) | Insight Medical Systems, Inc. | Neurology | database entry | |
| Automatic RegistrationK234047 · 510(k) | Brainlab AG | Neurology | database entry | |
| OTS HipK232140 · 510(k) | Ortoma AB | Neurology | database entry | |
| Spine PlanningK223553 · 510(k) | Brainlab AG | Neurology | database entry | |
| NuVasive Pulse SystemK180038 · 510(k) | NuVasive, Incorporated | Neurology | database entry |
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