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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 K241481
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 Received05/24/2024
Decision Date 10/16/2024
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
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