FDA 510(k)

Mikron Spinal Fixation System

N.º K: K171497 · 2017-10-12

SolicitanteMikron Makina Sanayi Ticaret Co. , Ltd.

Fecha de decisión2017-10-12

Código de productoMNI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Mikron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina Sanayi Ticaret Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171497. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Mikron Spinal Fixation System?

Mikron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Mikron Makina Sanayi Ticaret Co. , Ltd.. The 510(k) number is K171497.

When did Mikron Spinal Fixation System receive FDA 510(k) clearance?

Mikron Spinal Fixation System received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171497.

Who is the listed applicant for Mikron Spinal Fixation System?

The FDA 510(k) record lists Mikron Makina Sanayi Ticaret Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mikron Spinal Fixation System?

The FDA product code for Mikron Spinal Fixation System is MNI.

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Fuente oficial

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