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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 K243975
Device Name Knee+
Applicant
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Applicant Contact François Beaumont
Correspondent
Pixee Medical
18 rue Alain Savary
Besançon,  FR 25000
Correspondent Contact François Beaumont
Regulation Number882.4560
Classification Product Code
SBF  
Date Received12/23/2024
Decision Date 03/20/2025
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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