LnK Cervical Interbody Fusion Cage System— 510(k) K143360

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K143360 for LnK Cervical Interbody Fusion Cage System, Substantially Equivalent on 2015-04-03. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2014-11-24
Decision date: 2015-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Giheung-Gu, Yongin-Si, KR

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.