ZCA All-Poly Acetabular Cups

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 Cups.

Pre-market Notification Details

Device IDK191449
510k NumberK191449
Device Name:ZCA All-Poly Acetabular Cups
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
ContactCaleb Barylski
CorrespondentCaleb Barylski
Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-31
Decision Date2020-07-16

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