BALTEUM - ONE Lumbar Plate System— 510(k) K213820

Name: FDA 510(k) clearance K213820
Creator: U.S. Food and Drug Administration
Published: 2022-03-25

Substantially Equivalent

Huvexel Co. , Ltd.

FDA 510(k) clearance K213820 for BALTEUM - ONE Lumbar Plate System, Substantially Equivalent on 2022-03-25. Applicant: Huvexel Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Huvexel Co. , Ltd.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2021-12-08
Decision date: 2022-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.