THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM— 510(k) K043578

Substantially Equivalent

Solco Biomedical Co., Ltd.

FDA 510(k) clearance K043578 for THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM, Substantially Equivalent on 2005-03-07. Applicant: Solco Biomedical Co., Ltd..

Clearance details

Applicant: Solco Biomedical Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2004-12-28
Decision date: 2005-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.