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 a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2020-10-20 under approval 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. It is manufactured by Stryker Corporation. The 510(k) number is K202393.
When was SpineJack Expansion Kit approved by the FDA?
SpineJack Expansion Kit received FDA 510(k) clearance on 2020-10-20, under approval number K202393.
What company makes SpineJack Expansion Kit?
SpineJack Expansion Kit is manufactured by Stryker Corporation.
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.