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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 a medical device manufactured by Dragon Crown Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-06 under approval 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. It is manufactured by Dragon Crown Medical Co., Ltd.. The 510(k) number is K162283.

When was DCM Kyphoplasty System approved by the FDA?

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

What company makes DCM Kyphoplasty System?

DCM Kyphoplasty System is manufactured by Dragon Crown Medical Co., Ltd..

What is the FDA product code for DCM Kyphoplasty System?

The FDA product code for DCM Kyphoplasty System is NDN.

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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