FDA 510(k)

HC Spinal System

K-Number: K151362 · 2016-05-05

Decision Date2016-05-05

Product CodeMNH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HC Spinal System is a medical device manufactured by Hung Chun Bio-S Co., Ltd.. It received FDA 510(k) clearance on 2016-05-05 under approval number K151362. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HC Spinal System?

HC Spinal System is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by Hung Chun Bio-S Co., Ltd.. The 510(k) number is K151362.

When was HC Spinal System approved by the FDA?

HC Spinal System received FDA 510(k) clearance on 2016-05-05, under approval number K151362.

What company makes HC Spinal System?

HC Spinal System is manufactured by Hung Chun Bio-S Co., Ltd..

What is the FDA product code for HC Spinal System?

The FDA product code for HC Spinal System is MNH. This falls under the ENT category.

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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.