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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K203399
Device Name FITBONE(R) TAA
Applicant
Wittenstein Intens GmbH
Walter-Wittensstein-Strabe 1
Igersheim,  DE 97999
Applicant Contact Hartmut Kampa
Correspondent
Wagoner Consulting Llg
P.O. Box 15729
Wilmington,  NC  28408
Correspondent Contact Cheryl Wagoner
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/19/2020
Decision Date 02/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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