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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 K163368
Device Name FITBONE TAA
Applicant
Wittenstein Intens GmbH
Walter-Wittensstein-Strabe 1
Igersheim,  DE 97999
Applicant Contact Hartmut Kampa
Correspondent
Berlin Heart, Inc.
200 Valleywood Rd. Suite B100
The Woodlands,  TX  77338
Correspondent Contact Dudley Rajapaksa
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/30/2016
Decision Date 01/26/2017
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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