FDA 510(k)

Sequel External Fixation Device

N.º K: K202833 · 2021-01-19

Fecha de decisión2021-01-19

Código de productoKTT

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sequel External Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Sequel Medical, Inc.. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K202833. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sequel External Fixation Device?

Sequel External Fixation Device is a medical device that received FDA 510(k) clearance on 2021-01-19. The listed applicant is Sequel Medical, Inc.. The 510(k) number is K202833.

When did Sequel External Fixation Device receive FDA 510(k) clearance?

Sequel External Fixation Device received FDA 510(k) clearance on 2021-01-19, under 510(k) number K202833.

Who is the listed applicant for Sequel External Fixation Device?

The FDA 510(k) record lists Sequel Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sequel External Fixation Device?

The FDA product code for Sequel External Fixation Device is KTT.

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Fuente oficial

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