FDA cleared the xvision Spine system from Augmedics, Ltd. on Jul 31, 2026 under K261854, a traditional 510(k). The device falls under product code SBF, Orthopedic Augmented Reality, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.
FDA logged the submission as received on Jun 3, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Augmedics, Ltd. in the last 12 months of the tracker.
K261854 is the FDA 510(k) for xvision Spine system, submitted by Augmedics, Ltd.. FDA's decision date was Jul 31, 2026, under product code SBF (Orthopedic Augmented Reality).
Augmedics, Ltd., based in Yokneam Illit, is the applicant of record for K261854. The company is listed in the MedDevice Startups directory.
FDA received the submission on Jun 3, 2026 and issued its decision on Jul 31, 2026, 58 days later.
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