FDA 510(k)

FIXIT Threaded Anchor System

N.º K: K170868 · 2017-11-30

SolicitanteS.B.M Sas Science For Bio Materials

Fecha de decisión2017-11-30

Código de productoMAI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

FIXIT Threaded Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is S.B.M Sas Science For Bio Materials. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K170868. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FIXIT Threaded Anchor System?

FIXIT Threaded Anchor System is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is S.B.M Sas Science For Bio Materials. The 510(k) number is K170868.

When did FIXIT Threaded Anchor System receive FDA 510(k) clearance?

FIXIT Threaded Anchor System received FDA 510(k) clearance on 2017-11-30, under 510(k) number K170868.

Who is the listed applicant for FIXIT Threaded Anchor System?

The FDA 510(k) record lists S.B.M Sas Science For Bio Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXIT Threaded Anchor System?

The FDA product code for FIXIT Threaded Anchor System is MAI.

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Fuente oficial

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