G7® Vivacit-E® Freedom® Constrained Liner

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive

Zimmer, Inc.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for G7® Vivacit-e® Freedom® Constrained Liner.

Pre-market Notification Details

Device IDK212512
510k NumberK212512
Device Name:G7® Vivacit-E® Freedom® Constrained Liner
ClassificationProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive
Applicant Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
ContactRomil Sheth
CorrespondentAdam Haas
Zimmer, Inc. 1800 W. Center Street Warsaw,  IN  46580
Product CodePBI  
CFR Regulation Number888.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-10
Decision Date2022-04-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00889024588370 K212512 000

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