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FDA 510(k)

Mega Plus Spine System

K-Number: K173180 · 2018-03-15

ApplicantBk Meditech, Co., Ltd.
Decision Date2018-03-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mega Plus Spine System is a medical device manufactured by Bk Meditech, Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under approval number K173180. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mega Plus Spine System?

Mega Plus Spine System is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by Bk Meditech, Co., Ltd.. The 510(k) number is K173180.

When was Mega Plus Spine System approved by the FDA?

Mega Plus Spine System received FDA 510(k) clearance on 2018-03-15, under approval number K173180.

What company makes Mega Plus Spine System?

Mega Plus Spine System is manufactured by Bk Meditech, Co., Ltd..

What is the FDA product code for Mega Plus Spine System?

The FDA product code for Mega Plus Spine System is NKB.

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Other Devices by Bk Meditech, Co., Ltd.

K183080Mega Plus Spine System K200981Mega Plus MIS Spine System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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