DeviceClearance

K100706

Substantially Equivalent

VENUS BASIC SPINAL FIXATION SYSTEM

Applicant
L&K BIOMED Co., Ltd.
Product code
MNH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seoul, KR
Download summary PDF View on FDA.gov ↗

Adverse events under product code MNH

product code MNH
Injury
978
Malfunction
793
Total
1,771

Source: openFDA MAUDE database, through . 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.