4CIS® Marlin ACIF Cage System— 510(k) K162402

Substantially Equivalent

Solco Biomedical Co., Ltd.

FDA 510(k) clearance K162402 for 4CIS® Marlin ACIF Cage System, Substantially Equivalent on 2017-02-16. Applicant: Solco Biomedical Co., Ltd..

Clearance details

Applicant: Solco Biomedical Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2016-08-26
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.