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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, ankle, semi-constrained, cemented, metal/polymer
510(k) Number K171004
Device Name Hintermann Series H2 Total Ankle System
Dt MedTech LLC
110 West Road
Suite 227
Towson,  MD  21024
Applicant Contact Shawn T Huxel
M Squared Associates, Inc
575 8th Avenue
Suite 1212
New York,  NY  10018
Correspondent Contact Marcos Velez-Duran
Regulation Number888.3110
Classification Product Code
Date Received04/04/2017
Decision Date 11/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No