PathLoc-C Posterior Cervical Fixation System— 510(k) K153439

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K153439 for PathLoc-C Posterior Cervical Fixation System, Substantially Equivalent on 2016-07-21. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2015-11-27
Decision date: 2016-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Giheung-Gu, 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.