CastleLoc-S Posterior Cervical Fixation System— 510(k) K231840

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K231840 for CastleLoc-S Posterior Cervical Fixation System, Substantially Equivalent on 2023-07-20. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2023-06-22
Decision date: 2023-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.