ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM— 510(k) K112108

Substantially Equivalent

Spineart

FDA 510(k) clearance K112108 for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM, Substantially Equivalent on 2011-08-19. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2011-07-22
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

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.