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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 K252058
Device Name ROSA Knee System with UltraSound Imaging Platform (USIP)
Applicant
Balmoral Medical, LLC
9450 Bryn Mawr Ave.
Suite 200
Rosemont,  IL  60018
Applicant Contact Brett Zarda
Correspondent
Qserve Group, Us, Inc.
350 S. Main St. Suite 309
Doylestown,  PA  18901
Correspondent Contact Lorry Weaver
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
ITX   IYO   KKX  
Date Received07/01/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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