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FDA 510(k)

SpineJack® Expansion Kit

K-Number: K223294 · 2022-12-20

ApplicantStryker Instruments
Decision Date2022-12-20
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpineJack® Expansion Kit is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2022-12-20 under approval number K223294. 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 2022-12-20. It is manufactured by Stryker Instruments. The 510(k) number is K223294.

When was SpineJack® Expansion Kit approved by the FDA?

SpineJack® Expansion Kit received FDA 510(k) clearance on 2022-12-20, under approval number K223294.

What company makes SpineJack® Expansion Kit?

SpineJack® Expansion Kit is manufactured by Stryker Instruments.

What is the FDA product code for SpineJack® Expansion Kit?

The FDA product code for SpineJack® Expansion Kit is NDN.

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Related Devices (Code: NDN)

K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical , Ltd. K160983Kyphon HV-R Bone CementMedtronic, Inc. K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas

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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