Medline UNITE Ancillary Foot Recon Plating System— 510(k) K234031

Substantially Equivalent

Medline Industires, LP

FDA 510(k) clearance K234031 for Medline UNITE Ancillary Foot Recon Plating System, Substantially Equivalent on 2024-01-18. Applicant: Medline Industires, LP.

Clearance details

Applicant: Medline Industires, LP
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2023-12-20
Decision date: 2024-01-18
Decision: Substantially Equivalent
Clearance type: Special
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.