PROPHECY INVISION Pre-operative Navigation 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 Prophecy Invision Pre-operative Navigation System.

Pre-market Notification Details

Device IDK170968
510k NumberK170968
Device Name:PROPHECY INVISION Pre-operative Navigation 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 Received2017-03-31
Decision Date2017-08-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420194725 K170968 000

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