Medline Foot Plates and Screws— 510(k) K151235

Substantially Equivalent

Medline Industries, Inc.

FDA 510(k) clearance K151235 for Medline Foot Plates and Screws, Substantially Equivalent on 2015-08-06. Applicant: Medline Industries, Inc..

Clearance details

Applicant: Medline Industries, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2015-05-11
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, 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.