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FDA 510(k)

SpineJack Expansion Kit

K-Number: K181262 · 2018-08-30

ApplicantVexim SA
Decision Date2018-08-30
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the SpineJack Expansion Kit?

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

When was SpineJack Expansion Kit approved by the FDA?

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

What company makes SpineJack Expansion Kit?

SpineJack Expansion Kit is manufactured by Vexim SA.

What is the FDA product code for SpineJack Expansion Kit?

The FDA product code for SpineJack Expansion Kit is NDN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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