4CIS Marlin PEEK ACIF Cage— 510(k) K192044

Substantially Equivalent

Solco Biomedical Co., Ltd.

FDA 510(k) clearance K192044 for 4CIS Marlin PEEK ACIF Cage, Substantially Equivalent on 2019-12-19. Applicant: Solco Biomedical Co., Ltd..

Clearance details

Applicant: Solco Biomedical Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-07-31
Decision date: 2019-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyeongtaek-Si, 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.