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Balteum Lumbar Plate System

by Huvexel Co., Ltd.

510(k) K200846

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200846 Date5 May 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
FDA applicant
Huvexel Co. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Balteum Lumbar Plate System is a spinal intervertebral body fixation orthosis. It is indicated for use in conditions including scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spinal procedure.

This device is classified as a Class II orthopedic device under product code KWQ. It has received FDA 510k clearance through the traditional pathway under K200846.

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