K111127

Substantially Equivalent

ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Applicant: Spineart
Product code: MNI
Advisory panel: Orthopedic
Date received: 2011-04-21
Decision date: 2011-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Geneva, CH

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.