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Orthopedic Augmented Reality

FDA product code SBF · 43 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.4560
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-12-20 – 2026-07-31

An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view.

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