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FDA 510(k)

SpineKure Kyphoplasty System

K-Number: K172871 · 2018-05-29

ApplicantHanchang Co., Ltd.
Decision Date2018-05-29
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpineKure Kyphoplasty System is a medical device manufactured by Hanchang Co., Ltd.. It received FDA 510(k) clearance on 2018-05-29 under approval number K172871. 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 SpineKure Kyphoplasty System?

SpineKure Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2018-05-29. It is manufactured by Hanchang Co., Ltd.. The 510(k) number is K172871.

When was SpineKure Kyphoplasty System approved by the FDA?

SpineKure Kyphoplasty System received FDA 510(k) clearance on 2018-05-29, under approval number K172871.

What company makes SpineKure Kyphoplasty System?

SpineKure Kyphoplasty System is manufactured by Hanchang Co., Ltd..

What is the FDA product code for SpineKure Kyphoplasty System?

The FDA product code for SpineKure Kyphoplasty System is NDN.

Related Devices (Code: 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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