NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate— 510(k) K241754

Substantially Equivalent

Zimmer Switzerland Manufacturing GmbH

FDA 510(k) clearance K241754 for NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate, Substantially Equivalent on 2024-08-15. Applicant: Zimmer Switzerland Manufacturing GmbH.

Clearance details

Applicant: Zimmer Switzerland Manufacturing GmbH
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2024-06-18
Decision date: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winterthur, CH

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.