FDA 510(k)

Mega Plus Spine System

K-Number: K183080 · 2018-12-10

Decision Date2018-12-10

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 2018-12-10 under approval number K183080. 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 2018-12-10. It is manufactured by Bk Meditech, Co., Ltd.. The 510(k) number is K183080.

When was Mega Plus Spine System approved by the FDA?

Mega Plus Spine System received FDA 510(k) clearance on 2018-12-10, under approval number K183080.

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.

K173180Mega Plus Spine System K200981Mega Plus MIS Spine System

Related Devices (Code: NKB)

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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.