RIVAL View Plating Systems and Reduce Fracture Plating Systems— 510(k) K190388

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K190388 for RIVAL View Plating Systems and Reduce Fracture Plating Systems, Substantially Equivalent on 2019-06-07. Applicant: Orthofix Srl.

Clearance details

Applicant: Orthofix Srl
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2019-02-19
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bussolengo, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.