Implantcast Ic-Bipolar Head System

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

Implantcast, GmbH

The following data is part of a premarket notification filed by Implantcast, Gmbh with the FDA for Implantcast Ic-bipolar Head System.

Pre-market Notification Details

Device IDK191569
510k NumberK191569
Device Name:Implantcast Ic-Bipolar Head System
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant Implantcast, GmbH Luneburger Schanze 26 Buxtehude,  DE 21614
ContactJuliiane Hoppner
CorrespondentDave Mcgurl
Mcra, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeKWY  
Subsequent Product CodeLZO
Subsequent Product CodeMEH
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2019-08-28

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