FDA 510(k)

DePuy Synthes TFNA Augmentation System

N.º K: K160167 · 2016-09-26

Fecha de decisión2016-09-26

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DePuy Synthes TFNA Augmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K160167. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DePuy Synthes TFNA Augmentation System?

DePuy Synthes TFNA Augmentation System is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K160167.

When did DePuy Synthes TFNA Augmentation System receive FDA 510(k) clearance?

DePuy Synthes TFNA Augmentation System received FDA 510(k) clearance on 2016-09-26, under 510(k) number K160167.

Who is the listed applicant for DePuy Synthes TFNA Augmentation System?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes TFNA Augmentation System?

The FDA product code for DePuy Synthes TFNA Augmentation System is HSB.

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Fuente oficial

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