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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 K233725
Device Name Spine Navigation System
Applicant
Medivis, Inc.
920 Broadway
16th Floor
New York,  NY  10010
Applicant Contact Amy Lynn
Correspondent
Medivis, Inc.
920 Broadway
16th Floor
New York,  NY  10010
Correspondent Contact Amy Lynn
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/21/2023
Decision Date 07/26/2024
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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