FDA Product Code OLO: Orthopedic Stereotaxic Instrument
FDA product code OLO covers orthopedic stereotaxic instruments.
These are computer-assisted navigation systems that provide real-time spatial guidance during orthopedic joint and spine surgery. They help surgeons achieve precise implant placement and trajectory planning.
OLO devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Orthopedic panel. Neurological stereotaxic instruments are classified separately under product code HAW.
Leading manufacturers include THINK Surgical, Inc., Brainlab AG and Stryker Leibinger GmbH & Co KG.
List of Orthopedic Stereotaxic Instrument devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Orthopedic Stereotaxic Instrument devices (product code OLO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →