LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253906

    Validate with FDA (Live)

    Device Name
    Xpert Hand
    Manufacturer
    Newclip Technics
    Date Cleared
    2026-03-11

    (96 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K250155,K062498,K051567
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The implants of the Xpert Hand range are indicated for the fixation of hand fractures, osteotomies and arthrodeses in adults.

    Device Description

    The Xpert Hand range consists of plates and screws designed for the fixation of hand fractures, osteotomies and arthrodeses in adults.

    The plates and screws of the Xpert Hand range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use.

    The instruments of the Xpert Hand range will be provided non sterile for sterilization by health care professionals prior to use.

    Materials: CP Titanium grade 4 (conform to ASTM F67 and ISO 5832-2) for the plates, and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3) for the screws.

    Function: The implants of the Xpert Hand range are indicated for the fixation of hand fractures, osteotomies and arthrodeses in adults.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1