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FDA 510(k)

Meduloc Intramedullary Fracture Fixation (IFF) System

K-Number: K250316 · 2025-10-29

ApplicantMeduloc, LLC
Decision Date2025-10-29
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Meduloc Intramedullary Fracture Fixation (IFF) System is a medical device manufactured by Meduloc, LLC. It received FDA 510(k) clearance on 2025-10-29 under approval number K250316. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Meduloc Intramedullary Fracture Fixation (IFF) System?

Meduloc Intramedullary Fracture Fixation (IFF) System is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Meduloc, LLC. The 510(k) number is K250316.

When was Meduloc Intramedullary Fracture Fixation (IFF) System approved by the FDA?

Meduloc Intramedullary Fracture Fixation (IFF) System received FDA 510(k) clearance on 2025-10-29, under approval number K250316.

What company makes Meduloc Intramedullary Fracture Fixation (IFF) System?

Meduloc Intramedullary Fracture Fixation (IFF) System is manufactured by Meduloc, LLC.

What is the FDA product code for Meduloc Intramedullary Fracture Fixation (IFF) System?

The FDA product code for Meduloc Intramedullary Fracture Fixation (IFF) System is JDW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING NCT04389749 Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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