Avenir Muller Stem, Avenir Cemented Hip Stem

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

Zimmer GmbH

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

Pre-market Notification Details

Device IDK193030
510k NumberK193030
Device Name:Avenir Muller Stem, Avenir Cemented Hip Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant Zimmer GmbH Sulzerallee 8 Winterthur,  CH 8404
ContactRoberto Tommasini
CorrespondentMelanie Mitrov
Zimmer GmbH Sulzerallee 8 Winterthur,  CH 8404
Product CodeLZO  
Subsequent Product CodeKWL
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLWJ
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-30
Decision Date2019-12-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.