VENUS CERVICAL SPINAL FIXATION SYSTEM— 510(k) K103414

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K103414 for VENUS CERVICAL SPINAL FIXATION SYSTEM, Substantially Equivalent on 2011-07-22. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2010-11-22
Decision date: 2011-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.