LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981855
    Device Name
    PRINCE MEDICAL CEMENT PLUG
    Manufacturer
    PRINCE MEDICAL, INC.
    Date Cleared
    1998-08-10

    (76 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Prince Medical Cement Plug is indicated for use with cemented total hip or endoprosthetic femoral components to :

      1. Prevent the bone cement from distal migration during its insertion.
      1. Increase the pressure of the cement during cement and femoral component insertion to facilitate bone penetration and distribution of the cement.
    Device Description

    The Prince Medical Cement Plug consists of various sizes and is made from Medical Grade Ultra High Molecular Weight Polyethylene (UHMWPE). The component is produced in two outside diameters and is introduced into the medullary canal using a stainless steel inserting tool. Under this premarket notification, the device is available in 18.5 and 25.0mm outside diameter.

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary for the Prince Medical Cement Plug. It does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on describing the device, its materials, biocompatibility, sterilization, utilization, indications for use, and regulatory clearance based on substantial equivalence to previously marketed devices.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them from the provided text. The document is a regulatory approval notice, not a clinical study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1