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

FDA 510(k)

xvision Spine system (XVS)

K-Number: K190929 · 2019-12-20

ApplicantAugmedics, Ltd.
Decision Date2019-12-20
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

xvision Spine system (XVS) is a medical device manufactured by Augmedics, Ltd.. It received FDA 510(k) clearance on 2019-12-20 under approval number K190929. 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 (XVS)?

xvision Spine system (XVS) is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Augmedics, Ltd.. The 510(k) number is K190929.

When was xvision Spine system (XVS) approved by the FDA?

xvision Spine system (XVS) received FDA 510(k) clearance on 2019-12-20, under approval number K190929.

What company makes xvision Spine system (XVS)?

xvision Spine system (XVS) is manufactured by Augmedics, Ltd..

What is the FDA product code for xvision Spine system (XVS)?

The FDA product code for xvision Spine system (XVS) is SBF.

Related Clinical Trials

NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING

Other Devices by Augmedics, Ltd.

K211188xvision Spine system (XVS) K220905xvision Spine System K241481xvision Spine System K251639xvision Spine system K250255xvision Spine system

Related Devices (Code: SBF)

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. K202750Knee+Pixee Medical

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.

↑