LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250316
    Device Name
    Meduloc Intramedullary Fracture Fixation (IFF) System
    Manufacturer
    Meduloc, LLC
    Date Cleared
    2025-10-29

    (267 days)

    Product Code
    JDW,HTY,HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K131264
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Meduloc Intramedullary Fracture Fixation (IFF) System is intended for use in the fixation of long bone fractures in both adult and pediatric applications.

    Device Description

    The Meduloc Intramedullary Fracture Fixation (IFF) System is intended to treat small, long-bone fractures. It consists of three implants: Intramedullary Wire, Bone Anchor, and Locking Screw. The implants are provided in various sizes to accommodate varying patient anatomy. The system also contains a set of ancillary instruments. All elements of the System are Gamma sterilized and provided sterile-packed and are single-use.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1