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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 the device name listed in this FDA 510(k) record. The listed applicant is Dt Medtech, LLC. It received FDA 510(k) clearance on 2017-11-07 under 510(k) 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. The listed applicant is Dt Medtech, LLC. The 510(k) number is K171004.

When did Hintermann Series H2 Total Ankle System receive FDA 510(k) clearance?

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

Who is the listed applicant for Hintermann Series H2 Total Ankle System?

The FDA 510(k) record lists Dt Medtech, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04770870Post Approval Study2: Hintermann Series H3 Total Ankle Replacement SystemACTIVE_NOT_RECRUITING

Other records listing Dt Medtech, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160036Prosthesis, ankle, uncemented, non-constrained

Related Devices (Code: HSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

Official Source

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

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