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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K211188
Device Name xvision Spine system (XVS)
Applicant
Augmedics Ltd
1 Ha-Tsmikha St
Yokneam Illit,  IL 2069205
Applicant Contact Tami Harel
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/20/2021
Decision Date 07/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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