Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Balteum™ Lumbar Plate System

K-Number: K200846 · 2020-05-05

ApplicantHuvexel Co. , Ltd.
Decision Date2020-05-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Balteum™ 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 2020-05-05 under 510(k) 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. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K200846.

When did Balteum™ Lumbar Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for Balteum™ 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™ Lumbar Plate System?

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

Other records listing Huvexel Co. , Ltd. as applicant

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.

K213820BALTEUM - ONE™ Lumbar Plate SystemK191477AEON-C Stand Alone SystemK180729FaSet Fixation SystemK173201UNITY Sacroiliac Joint Fixation SystemK173131Rexious Spinal Fixation SystemK173099Fortis and Hana Anterior Cervical Plate System

View all 8 devices →

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.

↑