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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 K233899
Device Name Knee+
Applicant
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Applicant Contact Lucie Pecheur
Correspondent
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Correspondent Contact Lucie Pecheur
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/11/2023
Decision Date 03/08/2024
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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