Hintermann Series H2 Total Ankle System

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

Dt MedTech LLC

The following data is part of a premarket notification filed by Dt Medtech Llc with the FDA for Hintermann Series H2 Total Ankle System.

Pre-market Notification Details

Device IDK171004
510k NumberK171004
Device Name:Hintermann Series H2 Total Ankle System
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant Dt MedTech LLC 110 West Road Suite 227 Towson,  MD  21024
ContactShawn T Huxel
CorrespondentMarcos Velez-duran
M Squared Associates, Inc 575 8th Avenue Suite 1212 New York,  NY  10018
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-04
Decision Date2017-11-07
Summary:summary

NIH GUDID Devices

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