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FDA 510(k)

BALTEUM - ONE™ Lumbar Plate System

K-Number: K213820 · 2022-03-25

ApplicantHuvexel Co. , Ltd.
Decision Date2022-03-25
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BALTEUM - ONE™ Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) 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. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K213820.

When did BALTEUM - ONE™ Lumbar Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for BALTEUM - ONE™ Lumbar Plate System?

The FDA 510(k) record lists Huvexel Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Huvexel Co. , Ltd. as applicant

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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