5 devices · 4 companies · 2024 to 2025
Product code SBF: Orthopedic Augmented Reality
5 devices under product code SBF, 2024 to 2025, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Orthopedic Augmented Reality. 21 CFR 882.4560, Class II. 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 users field of view. MAUDE held 4 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 |
|---|---|---|---|---|
| xvision Spine systemK251639 · 510(k) | Augmedics, Ltd. | Neurology | database entry | |
| SpineAR SNAPK252054 · 510(k) | Surgical Theater, Inc. | Neurology | database entry | |
| xvision Spine systemK250255 · 510(k) | Augmedics Ltd. | Neurology | database entry | |
| ARVIS ShoulderK243950 · 510(k) | Kico Knee Innovation Company Pty Ltd | Neurology | database entry | |
| xvision Spine SystemK241481 · 510(k) | Augmedics Ltd. | Neurology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.