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510(k) Data Aggregation

    K Number
    K254253

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-24

    (85 days)

    Product Code
    Regulation Number
    888.3030
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K121495, K041860, K230141, K113652, K233008

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LOQTEQ® VA Proximal Humerus Plate 3.5 is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

    Device Description

    The subject device LOQTEQ® VA Proximal Humerus Short Plates are 21.5 mm wide at the proximal end, 12.4 mm wide along the shaft, and 3.2 mm thick. The shaft of each of the subject device short plates has one (1) oblong, non-locking screw hole, and 2, 3, 4, 5, or 6 VA (variable angle) locking 3.5 mm screw holes.

    The subject device LOQTEQ® VA Proximal Humerus Long Plates are 21.5 mm wide at the proximal end, 12.8 mm wide along the shaft, and 3.9 mm thick. The shaft of each of the subject device long plates has one (1) oblong, non-locking screw hole, one (1) VA 3.5 mm screw hole, and 6, 8, 10, 12, or 14 LOQTEQ® 3.5 mm gliding locking-compression screw holes.

    The subject device LOQTEQ® Cortical Screws have a standard cortical thread, 3.5 mm in diameter that tapers slightly at the tip. The heads of the screws are threaded to lock into the VA variable angle holes in the subject device plates. The screws are provided in overall lengths of 20 mm to 60 mm, in 2 mm increments.

    The subject device LOQTEQ® Cancellous Screws have a standard cancellous thread, 4.0 mm thread diameter that tapers slightly at the tip. The heads of the screws are threaded to lock into the VA variable angle holes in the subject device plates. The screws are provided in overall lengths of 20 mm to 60 mm, in 2 mm increments.

    The subject device plates and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.

    AI/ML Overview

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