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510(k) Data Aggregation

    K Number
    K250536
    Device Name
    MetaFore Small Screw System
    Manufacturer
    Extremity Medical, LLC
    Date Cleared
    2025-10-08

    (226 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K153182,K150772
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MetaFore Small Screw System is indicated for the fixation of bone fractures and for bone reconstruction in hand and forefoot surgery.

    Device Description

    The MetaFore Small Screw System consists of implantable screws, and accessories for use in arthrodesis procedures of the hand and forefoot. The screws consist of 2.0mm solid snap-off, 2.5 and 3.0mm cannulated headless and 3.0 and 4.0mm cannulated beveled available in various overall lengths and thread lengths. The screws are manufactured from titanium alloy (Ti-6Al-4V ELI) and provided sterile-packed. The instruments are manufactured primarily from surgical grade stainless steel and titanium and provided non-sterile.

    AI/ML Overview

    N/A

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