ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM— 510(k) K140948

Substantially Equivalent

Spineart

FDA 510(k) clearance K140948 for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM, Substantially Equivalent on 2014-05-20. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2014-04-14
Decision date: 2014-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Geneva, CH

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, 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.