FDA 510(k)

Hintermann Series H2 Total Ankle System

Numéro K : K171004 · 2017-11-07

Date de décision2017-11-07

Code produitHSN

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : HSN)

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Source officielle

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