Medline UNITE Calcaneal Fracture Plating System— 510(k) K213567

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K213567 for Medline UNITE Calcaneal Fracture Plating System, Substantially Equivalent on 2022-03-02. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2021-11-09
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, 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.