The following data is part of a premarket notification filed by Dt Medtech Llc with the FDA for Hintermann Series H2 Total Ankle System.
Device ID | K171004 |
510k Number | K171004 |
Device Name: | Hintermann Series H2 Total Ankle System |
Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
Applicant | Dt MedTech LLC 110 West Road Suite 227 Towson, MD 21024 |
Contact | Shawn T Huxel |
Correspondent | Marcos Velez-duran M Squared Associates, Inc 575 8th Avenue Suite 1212 New York, NY 10018 |
Product Code | HSN |
CFR Regulation Number | 888.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-04 |
Decision Date | 2017-11-07 |
Summary: | summary |
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