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FDA 510(k)

Hintermann Series H2 Total Ankle System

K-Number: K171004 · 2017-11-07

ApplicantDt Medtech, LLC
Decision Date2017-11-07
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hintermann Series H2 Total Ankle System is a medical device manufactured by Dt Medtech, LLC. It received FDA 510(k) clearance on 2017-11-07 under approval number K171004. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hintermann Series H2 Total Ankle System?

Hintermann Series H2 Total Ankle System is a medical device that received FDA 510(k) clearance on 2017-11-07. It is manufactured by Dt Medtech, LLC. The 510(k) number is K171004.

When was Hintermann Series H2 Total Ankle System approved by the FDA?

Hintermann Series H2 Total Ankle System received FDA 510(k) clearance on 2017-11-07, under approval number K171004.

What company makes Hintermann Series H2 Total Ankle System?

Hintermann Series H2 Total Ankle System is manufactured by Dt Medtech, LLC.

What is the FDA product code for Hintermann Series H2 Total Ankle System?

The FDA product code for Hintermann Series H2 Total Ankle System is HSN.

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Related PubMed Literature

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Other Devices by Dt Medtech, LLC

PMA P160036Prosthesis, ankle, uncemented, non-constrained

Related Devices (Code: HSN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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