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

Name: FDA 510(k) clearance K250316
Creator: U.S. Food and Drug Administration
Published: 2025-10-29

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. Device class: 2.

Clearance details

Applicant: Meduloc, LLC
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
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 ↗

Recent devices under product code JDW

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K260073 — XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm2026-02-10
K241357 — XT3 System2025-01-22
K223112 — MAVERICK Mini External Fixation System2022-12-08
K213874 — MAVERICK External Fixation System2022-02-11
K211508 — Steinmann Pins and Kirschner Wires2021-10-05

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.