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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 K250108
Device Name OptiVu™ Shoulder
Applicant
Mr Surgical Solutions, LLC
425 Fayette St.
#617
Conshohocken,  PA  19428
Applicant Contact Brian Karpinski
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Kyle Kovach
Regulation Number882.4560
Classification Product Code
SBF  
Date Received01/16/2025
Decision Date 07/09/2025
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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