FDA 510(k)

G3(TM) Active Plate(R) Small Fragment System

Número K: K160633 · 2016-04-22

Data da decisão2016-04-22

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

G3(TM) Active Plate(R) Small Fragment System is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Fracture Care, Inc.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160633. 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 G3(TM) Active Plate(R) Small Fragment System?

G3(TM) Active Plate(R) Small Fragment System is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Genesis Fracture Care, Inc.. The 510(k) number is K160633.

When did G3(TM) Active Plate(R) Small Fragment System receive FDA 510(k) clearance?

G3(TM) Active Plate(R) Small Fragment System received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160633.

Who is the listed applicant for G3(TM) Active Plate(R) Small Fragment System?

The FDA 510(k) record lists Genesis Fracture Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G3(TM) Active Plate(R) Small Fragment System?

The FDA product code for G3(TM) Active Plate(R) Small Fragment System is HRS.

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Outros registros que listam Genesis Fracture Care, Inc. como candidato(a)

K171293G3™ Active Plate® Miniature System

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