FDA 510(k)

Balteum Lumbar Plate System

K-Number: K200846 · 2020-05-05

Decision Date2020-05-05

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Balteum Lumbar Plate System is a medical device manufactured by Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2020-05-05 under approval number K200846. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Balteum Lumbar Plate System?

Balteum Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2020-05-05. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K200846.

When was Balteum Lumbar Plate System approved by the FDA?

Balteum Lumbar Plate System received FDA 510(k) clearance on 2020-05-05, under approval number K200846.

What company makes Balteum Lumbar Plate System?

Balteum Lumbar Plate System is manufactured by Huvexel Co. , Ltd..

What is the FDA product code for Balteum Lumbar Plate System?

The FDA product code for Balteum Lumbar Plate System is KWQ.

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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.