Affixus Tibial Nailing System - 4mm screws— 510(k) K243907

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K243907 for Affixus Tibial Nailing System - 4mm screws, Substantially Equivalent on 2025-02-12. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2024-12-19
Decision date: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.