WAGNER CONE PROSTHESIS SYSTEM

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 Wagner Cone Prosthesis System.

Pre-market Notification Details

Device IDK113556
510k NumberK113556
Device Name:WAGNER CONE PROSTHESIS SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactDaniel J William
CorrespondentDaniel J William
ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeKWZ
Subsequent Product CodeLPH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-01
Decision Date2012-02-17
Summary:summary

NIH GUDID Devices

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