FDA 510(k)

Chiral Surgical Pedicle Screw System

N.º K: K181995 · 2018-09-20

Fecha de decisión2018-09-20

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Chiral Surgical Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Chiral Surgical. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K181995. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Chiral Surgical Pedicle Screw System?

Chiral Surgical Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Chiral Surgical. The 510(k) number is K181995.

When did Chiral Surgical Pedicle Screw System receive FDA 510(k) clearance?

Chiral Surgical Pedicle Screw System received FDA 510(k) clearance on 2018-09-20, under 510(k) number K181995.

Who is the listed applicant for Chiral Surgical Pedicle Screw System?

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

What is the FDA product code for Chiral Surgical Pedicle Screw System?

The FDA product code for Chiral Surgical Pedicle Screw System is NKB.

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Fuente oficial

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