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FDA 510(k)

MEDINAUT Kyphoplasty System

K-Number: K153296 · 2016-07-29

ApplicantImedicom Co., Ltd.
Decision Date2016-07-29
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDINAUT Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K153296. 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 MEDINAUT Kyphoplasty System?

MEDINAUT Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K153296.

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

MEDINAUT Kyphoplasty System received FDA 510(k) clearance on 2016-07-29, under 510(k) number K153296.

Who is the listed applicant for MEDINAUT Kyphoplasty System?

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

What is the FDA product code for MEDINAUT Kyphoplasty System?

The FDA product code for MEDINAUT Kyphoplasty System is NDN.

Other records listing Imedicom Co., Ltd. as applicant

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.

K182287MEDINAUT PlusK173541EPINAUTK150915SPINAUT-PK151268SPINAUT-V, SPINAUT-S, SPINAUT-IK150789SPINAUT-E, SPINAUT-I

Related Devices (Code: NDN)

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.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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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