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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Augmented Reality
510(k) Number K250255
Device Name xvision Spine system
Applicant
Augmedics, Ltd.
2 Ha-Otsma St.
Yokneam Illit,  IL 2069205
Applicant Contact Tami Harel
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number882.4560
Classification Product Code
SBF  
Date Received01/28/2025
Decision Date 03/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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