K250892

Substantially Equivalent

CastleLoc Pectus Bar System

Applicant: L&K BIOMED Co., Ltd.
Product code: HRS
Advisory panel: Orthopedic
Date received: 2025-03-25
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Yongin-Si, KR

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.