LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974785
    Device Name
    AUTO-DRIVE BONE SCREW
    Manufacturer
    OSTEOMED CORP.
    Date Cleared
    1998-03-18

    (86 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K944565,K970912
    Why did this record match?
    Device Name :

    AUTO-DRIVE BONE SCREW

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

    Fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand

    Device Description

    The Auto-Drive™ bone screws are available in 1.6 mm and 2.0 mm diameters with lengths ranging from 4 mm to 8 mm.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

    The provided text is a 510(k) summary and approval letter for the OsteoMed Auto-Drive Bone Screw, focusing on its substantial equivalence to previously marketed devices. It describes the device's intended use, materials, design, and operational principle, and states that equivalence is based on these similarities. It does not contain any details about a study conducted to prove the device meets specific acceptance criteria in terms of performance metrics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1