PathLoc-SI Joint Fusion System— 510(k) K153656

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K153656 for PathLoc-SI Joint Fusion System, Substantially Equivalent on 2016-11-14. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2015-12-21
Decision date: 2016-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Giheung-Gu, Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.