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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 K202750
Device Name Knee+
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Applicant Contact Lucie Pecheur
Pixee Medical
18 rue Alain Savary
Besancon,  FR 25000
Correspondent Contact Lucie PECHEUR
Regulation Number882.4560
Classification Product Code
Date Received09/21/2020
Decision Date 04/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No