LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050699
    Device Name
    MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
    Manufacturer
    AMEDICA CORP.
    Date Cleared
    2005-04-15

    (28 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022729,K040276
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vented Cement Restrictor is intended for use as a cement restrictor used in the treatment of the following:

    • Total Hip Arthroplasty .
    • Total Knee Arthroplasty .
    • Total or Hemi Shoulder Arthroplasty .
      The device is not intended for use in spinal surgeries.
    Device Description

    The Vented Cement Restrictor used in cemented applications for hip, knee, and shoulder THE Vented Outlier (Sollieter Less The Vented Cement Restrictor features a ball valve which arthropiasty, is a polymorio abothe e stem, thus alleviating distal intra-medullary air pressure Surely Vonto an trapped chanufactured from either the above material or from a ceramic material.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) summary for a "Vented Cement Restrictor", focusing on its description, intended use, and substantial equivalence to predicate devices, but it does not include details on performance studies with acceptance criteria, sample sizes, ground truth, or expert involvement.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1