VENUS BASIC SPINAL FIXATION SYSTEM— 510(k) K103085

Substantially Equivalent

L&K BIOMED Co., Ltd.

FDA 510(k) clearance K103085 for VENUS BASIC SPINAL FIXATION SYSTEM, Substantially Equivalent on 2011-02-09. Applicant: L&K BIOMED Co., Ltd..

Clearance details

Applicant: L&K BIOMED Co., Ltd.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2010-10-19
Decision date: 2011-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Geumcheon-Gu, Seoul, KR

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.