FDA 510(k)

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5

N.º K: K161696 · 2016-11-23

Fecha de decisión2016-11-23

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 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 2016-11-23 under 510(k) number K161696. 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 aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Aap Implantate AG. The 510(k) number is K161696.

When did aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 receive FDA 510(k) clearance?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 received FDA 510(k) clearance on 2016-11-23, under 510(k) number K161696.

Who is the listed applicant for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

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 aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

The FDA product code for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is HRS.

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Otros registros que enlistan a Aap Implantate AG como solicitante

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Fuente oficial

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