SternaFuse Fixation System— 510(k) K202914

Substantially Equivalent

Fusion Innovations, LLC

FDA 510(k) clearance K202914 for SternaFuse Fixation System, Substantially Equivalent on 2022-01-26. Applicant: Fusion Innovations, LLC.

Clearance details

Applicant: Fusion Innovations, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2020-09-29
Decision date: 2022-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rock Hill, SC, 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.