PROPHECY Preoperative Navigation Alignment 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 Preoperative Navigation Alignment System.

Pre-market Notification Details

Device IDK202815
510k NumberK202815
Device Name:PROPHECY Preoperative Navigation Alignment System
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant Wright Medical Technology, Inc. 10801 Nesbitt Ave S Bloomington,  MN  55437
ContactPaxia Her
CorrespondentPaxia Her
Wright Medical Technology, Inc. 10801 Nesbitt Ave S Bloomington,  MN  55437
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-24
Decision Date2021-03-10

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