FDA Product Code SBF: Orthopedic Augmented Reality
FDA product code SBF covers orthopedic augmented reality systems — an emerging category of surgical guidance technology.
These devices overlay preoperative imaging data onto the surgeon's real-time view of the patient through a head-mounted display or projection system, enabling visualization of bone anatomy, implant positioning, and surgical targets without looking away from the operative field. They represent an evolution beyond conventional navigation by eliminating the need for a separate monitor.
SBF devices are Class II medical devices, regulated under 21 CFR 882.4560 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medacta International S.A., Globus Medical, Inc. and Brainlab AG.
List of Orthopedic Augmented Reality devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Orthopedic Augmented Reality devices (product code SBF). 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 →