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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 the device name listed in this FDA 510(k) record. The listed applicant is Hanchang Co., Ltd.. It received FDA 510(k) clearance on 2018-05-29 under 510(k) 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. The listed applicant is Hanchang Co., Ltd.. The 510(k) number is K172871.

When did SpineKure Kyphoplasty System receive FDA 510(k) clearance?

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

Who is the listed applicant for SpineKure Kyphoplasty System?

The FDA 510(k) record lists Hanchang Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpineKure Kyphoplasty System?

The FDA product code for SpineKure Kyphoplasty System is NDN.

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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

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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