FDA 510(k)

SpineJack Expansion Kit

K-Number: K181262 · 2018-08-30

Decision Date2018-08-30

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: NDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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