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 Brainlab AG, THINK Surgical, Inc. and Mako Surgical Corp..