Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

xvision Spine system

K-Number: K261854 · 2026-07-31

ApplicantAugmedics, Ltd.
Decision Date2026-07-31
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

xvision Spine system is the device name listed in this FDA 510(k) record. The listed applicant is Augmedics, Ltd.. It received FDA 510(k) clearance on 2026-07-31 under 510(k) number K261854. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xvision Spine system?

xvision Spine system is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Augmedics, Ltd.. The 510(k) number is K261854.

When did xvision Spine system receive FDA 510(k) clearance?

xvision Spine system received FDA 510(k) clearance on 2026-07-31, under 510(k) number K261854.

Who is the listed applicant for xvision Spine system?

The FDA 510(k) record lists Augmedics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for xvision Spine system?

The FDA product code for xvision Spine system is SBF.

Other records listing Augmedics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251639xvision Spine systemK250255xvision Spine systemK241481xvision Spine SystemK220905xvision Spine SystemK211188xvision Spine system (XVS)K190929xvision Spine system (XVS)

View all 7 devices →

Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLCK251737NextAR(TM) Shoulder PlatformMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑