LnK Posterior Cervical Fixation System— 510(k) K143278

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K143278 for LnK Posterior Cervical Fixation System, Substantially Equivalent on 2015-07-29. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2014-11-14
Decision date: 2015-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Giheung-Gu, Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.