INVISION Total Ankle Revision 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 Invision Total Ankle Revision System.

Pre-market Notification Details

Device IDK180730
510k NumberK180730
Device Name:INVISION Total Ankle Revision System
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
ContactAlayne Melancon
CorrespondentAlayne Melancon
Wright Medical Technology, Inc. 1023 Cherry Road Memphis,  TN  38117
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-20
Decision Date2018-07-11
Summary:summary

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