SYNTHES (USA) ORIBITAL MESH PLATES— 510(k) K001311

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K001311 for SYNTHES (USA) ORIBITAL MESH PLATES, Substantially Equivalent on 2000-06-20. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2000-04-25
Decision date: 2000-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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.