Fitmore Hip Stem

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

Zimmer GmbH

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Fitmore Hip Stem.

Pre-market Notification Details

Device IDK192236
501k NumberK192236
Device Name:Fitmore Hip Stem
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant Zimmer GmbH Sulzer Allee 8 Winterthur,  CH 8404
ContactRoberto Tommasini
CorrespondentTobias Moller
Zimmer GmbH Sulzer Allee 8 Winterthur,  CH 8404
Product CodeKWY  
Subsequent Product CodeJDI
Subsequent Product CodeKWL
Subsequent Product CodeKWZ
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2019-11-05

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.