Medline UNITE® REFLEX® Nitinol Staple System— 510(k) K231885

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K231885 for Medline UNITE® REFLEX® Nitinol Staple System, Substantially Equivalent on 2023-08-09. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2023-06-27
Decision date: 2023-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.