FDA 510(k)

SpineJack Expansion Kit

K-번호: K181262 · 2018-08-30

결정일2018-08-30

제품 코드NDN

자문 위원회OR

결정Substantially Equivalent

기기 요약

SpineJack Expansion Kit is the device name listed in this FDA 510(k) record. The listed applicant is Vexim SA. It received FDA 510(k) clearance on 2018-08-30 under 510(k) number K181262. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SpineJack Expansion Kit?

SpineJack Expansion Kit is a medical device that received FDA 510(k) clearance on 2018-08-30. The listed applicant is Vexim SA. The 510(k) number is K181262.

When did SpineJack Expansion Kit receive FDA 510(k) clearance?

SpineJack Expansion Kit received FDA 510(k) clearance on 2018-08-30, under 510(k) number K181262.

Who is the listed applicant for SpineJack Expansion Kit?

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

What is the FDA product code for SpineJack Expansion Kit?

The FDA product code for SpineJack Expansion Kit is NDN.

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SpineJack Expansion Kit

기기 요약

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관련 임상시험

관련 기기 (코드: NDN)

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