Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System— 510(k) K231262

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K231262 for Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System, Substantially Equivalent on 2023-08-18. Applicant: Stryker GmbH.

Clearance details

Applicant: Stryker GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2023-05-01
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, 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.