Cleared Traditional

Meduloc Intramedullary Fracture Fixation (IFF) System

K250316 · Meduloc, LLC · Orthopedic

Oct 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K250316 is an FDA 510(k) clearance for the Meduloc Intramedullary Fracture Fixation (IFF) System, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Meduloc, LLC (Del Mar, US). The FDA issued a Cleared decision on October 29, 2025, 267 days after receiving the submission on February 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K250316 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2025
Decision Date	October 29, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF