K042928

Substantially Equivalent

MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM

Applicant: U&I Corp.
Product code: MNH
Advisory panel: Orthopedic
Date received: 2004-10-22
Decision date: 2005-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Uijungbu, Gyeonggi-Do, KR

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.