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FDA 510(k)

SpineJack Expansion Kit

K-Number: K202393 · 2020-10-20

ApplicantStryker Corporation
Decision Date2020-10-20
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 Stryker Corporation. It received FDA 510(k) clearance on 2020-10-20 under 510(k) number K202393. 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 2020-10-20. The listed applicant is Stryker Corporation. The 510(k) number is K202393.

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

SpineJack Expansion Kit received FDA 510(k) clearance on 2020-10-20, under 510(k) number K202393.

Who is the listed applicant for SpineJack Expansion Kit?

The FDA 510(k) record lists Stryker Corporation 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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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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