FITBONE(R) TAA

Rod, Fixation, Intramedullary And Accessories

WITTENSTEIN Intens GmbH

The following data is part of a premarket notification filed by Wittenstein Intens Gmbh with the FDA for Fitbone(r) Taa.

Pre-market Notification Details

Device IDK203399
510k NumberK203399
Device Name:FITBONE(R) TAA
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant WITTENSTEIN Intens GmbH Walter-Wittensstein-StraBe 1 Igersheim,  DE 97999
ContactHartmut Kampa
CorrespondentCheryl Wagoner
Wagoner Consulting LLG P O Box 15729 Wilmington,  NC  28408
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-19
Decision Date2021-02-17

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