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FDA 510(k)

DCM Kyphoplasty System

K-Number: K162283 · 2017-02-06

ApplicantDragon Crown Medical Co., Ltd.
Decision Date2017-02-06
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DCM Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Dragon Crown Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-06 under 510(k) number K162283. 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 DCM Kyphoplasty System?

DCM Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2017-02-06. The listed applicant is Dragon Crown Medical Co., Ltd.. The 510(k) number is K162283.

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

DCM Kyphoplasty System received FDA 510(k) clearance on 2017-02-06, under 510(k) number K162283.

Who is the listed applicant for DCM Kyphoplasty System?

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

What is the FDA product code for DCM Kyphoplasty System?

The FDA product code for DCM 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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