FDA 510(k)

Humerus & Ulna System

Número K: K213108 · 2022-11-04

RequerenteAuxein Medical Private Limited

Data da decisão2022-11-04

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Humerus & Ulna System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K213108. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Humerus & Ulna System?

Humerus & Ulna System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K213108.

When did Humerus & Ulna System receive FDA 510(k) clearance?

Humerus & Ulna System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K213108.

Who is the listed applicant for Humerus & Ulna System?

The FDA 510(k) record lists Auxein Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Humerus & Ulna System?

The FDA product code for Humerus & Ulna System is HRS.

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Outros registros que listam Auxein Medical Private Limited como candidato(a)

K221787Auxein's DHS/DCS Plate System K213059Tibia and Fibula System K213110Parafuso de Sutura AUTOLOCK PEEK OPTIMA, Parafuso de Ancoragem AUTOLOCK ROTADOR PEEK OPTIMA K213018Auxilock GFS Mini, GFS II Large, and GFS Ultimate K213014Varixis Elbow System K213109Auxilock Draw Tight Suture-Based Anchor

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Fonte oficial

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