FDA 510(k)

BALTEUM - ONE Lumbar Plate System

K-Number: K213820 · 2022-03-25

Decision Date2022-03-25

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BALTEUM - ONE Lumbar Plate System is a medical device manufactured by Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2022-03-25 under approval number K213820. 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 - ONE Lumbar Plate System?

BALTEUM - ONE Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Huvexel Co. , Ltd.. The 510(k) number is K213820.

When was BALTEUM - ONE Lumbar Plate System approved by the FDA?

BALTEUM - ONE Lumbar Plate System received FDA 510(k) clearance on 2022-03-25, under approval number K213820.

What company makes BALTEUM - ONE Lumbar Plate System?

BALTEUM - ONE Lumbar Plate System is manufactured by Huvexel Co. , Ltd..

What is the FDA product code for BALTEUM - ONE Lumbar Plate System?

The FDA product code for BALTEUM - ONE Lumbar Plate System is KWQ.

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Related Devices (Code: 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.