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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 K230789
Device Name Knee+
Applicant
Pixee Medical
14 rue Alain Savary
Besancon,  FR 25000
Applicant Contact Lucie Pécheur
Correspondent
Pixee Medical
14 rue Alain Savary
Besancon,  FR 25000
Correspondent Contact Lucie Pécheur
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/22/2023
Decision Date 04/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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