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FDA 510(k)

xvision Spine system

K-Number: K251639 · 2025-10-03

ApplicantAugmedics, Ltd.
Decision Date2025-10-03
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

xvision Spine system is a medical device manufactured by Augmedics, Ltd.. It received FDA 510(k) clearance on 2025-10-03 under approval number K251639. 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 2025-10-03. It is manufactured by Augmedics, Ltd.. The 510(k) number is K251639.

When was xvision Spine system approved by the FDA?

xvision Spine system received FDA 510(k) clearance on 2025-10-03, under approval number K251639.

What company makes xvision Spine system?

xvision Spine system is manufactured by Augmedics, Ltd..

What is the FDA product code for xvision Spine system?

The FDA product code for xvision Spine system is SBF.

Related Clinical Trials

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Other Devices by Augmedics, Ltd.

K190929xvision Spine system (XVS) K211188xvision Spine system (XVS) K220905xvision Spine System K241481xvision Spine System K250255xvision Spine system

Related Devices (Code: SBF)

K190929xvision Spine system (XVS)Augmedics, Ltd. K202152NextAR TKA PlatformMedacta International S.A. K193559NextAR TKA PlatformMedacta Inernational SA K210859NextAR™ Spine PlatformMedacta International S.A. K211188xvision Spine system (XVS)Augmedics, Ltd. K210153NextAR RSA 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.

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