Xvision Spine System

Orthopedic Stereotaxic Instrument

Augmedics Ltd.

The following data is part of a premarket notification filed by Augmedics Ltd. with the FDA for Xvision Spine System.

Pre-market Notification Details

Device IDK220905
510k NumberK220905
Device Name:Xvision Spine System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Augmedics Ltd. 1 Ha-Tsmikha St Yokneam Illit,  IL 2069205
ContactContact Title
CorrespondentJanice M. Hogan
Hogan Lovells, US LLP 1735 Market Street, Floor 23 Philadelphia,  PA  19103
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-11-17

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