4CIS® Chiron Spinal Fixation System— 510(k) K231655

Substantially Equivalent

Solco Biomedical Co., Ltd.

FDA 510(k) clearance K231655 for 4CIS® Chiron Spinal Fixation System, Substantially Equivalent on 2024-11-26. Applicant: Solco Biomedical Co., Ltd..

Clearance details

Applicant: Solco Biomedical Co., Ltd.
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2023-06-06
Decision date: 2024-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Pyeongtaek-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.