Medline UNITE® REFLEX® Hybrid Nitinol Implant System— 510(k) K243888

Substantially Equivalent

Medline Industries, LP

FDA 510(k) clearance K243888 for Medline UNITE® REFLEX® Hybrid Nitinol Implant System, Substantially Equivalent on 2025-04-11. Applicant: Medline Industries, LP.

Clearance details

Applicant: Medline Industries, LP
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2024-12-18
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfield, 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.