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FDA 510(k)

KMC KYPHOPLASTY SYSTEM

K-Number: K113742 · 2012-09-17

ApplicantShanghai Kinetic Medical Co., Ltd.
Decision Date2012-09-17
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMC KYPHOPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kinetic Medical Co., Ltd.. It received FDA 510(k) clearance on 2012-09-17 under 510(k) number K113742. 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 KMC KYPHOPLASTY SYSTEM?

KMC KYPHOPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-17. The listed applicant is Shanghai Kinetic Medical Co., Ltd.. The 510(k) number is K113742.

When did KMC KYPHOPLASTY SYSTEM receive FDA 510(k) clearance?

KMC KYPHOPLASTY SYSTEM received FDA 510(k) clearance on 2012-09-17, under 510(k) number K113742.

Who is the listed applicant for KMC KYPHOPLASTY SYSTEM?

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

What is the FDA product code for KMC KYPHOPLASTY SYSTEM?

The FDA product code for KMC KYPHOPLASTY SYSTEM is NDN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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