ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zca All-poly Acetabular Cup, Snap-in, Model 8005-946/958-32.

Pre-market Notification Details

Device IDK030153
510k NumberK030153
Device Name:ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactKaren Cain
CorrespondentKaren Cain
ZIMMER, INC. P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-16
Decision Date2003-04-01
Summary:summary

NIH GUDID Devices

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