INFINITY TOTAL ANKLE SYSTEM

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

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Infinity Total Ankle System.

Pre-market Notification Details

Device IDK140749
510k NumberK140749
Device Name:INFINITY TOTAL ANKLE SYSTEM
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis,  TN  38117
ContactJeanine Redden
CorrespondentJeanine Redden
WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis,  TN  38117
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-25
Decision Date2014-04-25
Summary:summary

NIH GUDID Devices

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