FDA 510(k)

MEDINAUT Kyphoplasty System

K-Number: K153296 · 2016-07-29

Decision Date2016-07-29

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MEDINAUT Kyphoplasty System is a medical device manufactured by Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-07-29 under approval 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. It is manufactured by Imedicom Co., Ltd.. The 510(k) number is K153296.

When was MEDINAUT Kyphoplasty System approved by the FDA?

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

What company makes MEDINAUT Kyphoplasty System?

MEDINAUT Kyphoplasty System is manufactured by Imedicom Co., Ltd..

What is the FDA product code for MEDINAUT Kyphoplasty System?

The FDA product code for MEDINAUT Kyphoplasty System is NDN.

Other Devices by Imedicom Co., Ltd.

K150915SPINAUT-P K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I K173541EPINAUT K182287MEDINAUT Plus

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. 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 K163032Kyphon Xpede Bone CementMedtronic, Inc.

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.