FDA 510(k)

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer

N.º K: K161703 · 2016-11-04

Fecha de decisión2016-11-04

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is the device name listed in this FDA 510(k) record. The listed applicant is Aap Implantate AG. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161703. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer?

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Aap Implantate AG. The 510(k) number is K161703.

When did LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer receive FDA 510(k) clearance?

LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161703.

Who is the listed applicant for LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer?

The FDA 510(k) record lists Aap Implantate AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer?

The FDA product code for LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer is HRS.

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Fuente oficial

Ver en la base de datos de la FDA →

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