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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 the device name listed in this FDA 510(k) record. The listed applicant is Meduloc, LLC. It received FDA 510(k) clearance on 2025-10-29 under 510(k) 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. The listed applicant is Meduloc, LLC. The 510(k) number is K250316.

When did Meduloc Intramedullary Fracture Fixation (IFF) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Meduloc Intramedullary Fracture Fixation (IFF) System?

The FDA 510(k) record lists Meduloc, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07511478Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle FracturesCOMPLETED

Related Devices (Code: JDW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbHK210784Extended HA Half PinsSmith & Nephew, Inc.

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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