Meduloc Intramedullary Fracture Fixation (IFF) System— 510(k) K250316

Substantially Equivalent

Meduloc, LLC

FDA 510(k) clearance K250316 for Meduloc Intramedullary Fracture Fixation (IFF) System, Substantially Equivalent on 2025-10-29. Applicant: Meduloc, LLC.

Clearance details

Applicant: Meduloc, LLC
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2025-02-04
Decision date: 2025-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Del Mar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.