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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
Applicant
Dt Medtech, LLC
110 W. Rd., Suite 227
Towson,  MD  21024
Applicant Contact Shawn T Huxel
Correspondent
Msquared Associates, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact Marcos Velez-Duran
Regulation Number888.3110
Classification Product Code
HSN  
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
Predetermined Change
Control Plan Authorized		 No
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