FDA 510(k)

MSFX Mikron Cervical Anterior Plate System

Número K: K240484 · 2024-04-17

RequerenteMikron Makina Sanayi VE Ticaret Ltd. Sti.

Data da decisão2024-04-17

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MSFX Mikron Cervical Anterior Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina Sanayi VE Ticaret Ltd. Sti.. It received FDA 510(k) clearance on 2024-04-17 under 510(k) number K240484. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MSFX Mikron Cervical Anterior Plate System?

MSFX Mikron Cervical Anterior Plate System is a medical device that received FDA 510(k) clearance on 2024-04-17. The listed applicant is Mikron Makina Sanayi VE Ticaret Ltd. Sti.. The 510(k) number is K240484.

When did MSFX Mikron Cervical Anterior Plate System receive FDA 510(k) clearance?

MSFX Mikron Cervical Anterior Plate System received FDA 510(k) clearance on 2024-04-17, under 510(k) number K240484.

Who is the listed applicant for MSFX Mikron Cervical Anterior Plate System?

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

What is the FDA product code for MSFX Mikron Cervical Anterior Plate System?

The FDA product code for MSFX Mikron Cervical Anterior Plate System is KWQ.

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Fonte oficial

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