MatrixRIB Fixation System— 510(k) K161590

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K161590 for MatrixRIB Fixation System, Substantially Equivalent on 2016-11-03. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-06-09
Decision date: 2016-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, 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.