LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K100313
    Device Name
    HYDROFIX SURGICAL SHEET
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2011-06-14

    (495 days)

    Product Code
    FTL, CLA
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIMEDX GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.
    Device Description
    The HydroFix™ Surgical Sheet is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions 60 ±6 mm X 50 ±5 mm and 60 ±6 mm X 100 ±10 mm with a thickness of 1.0 ±0.2 mm. The comers of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution. The HydroFix™ Surgical Sheet will be provided in other shapes and sizes as needed for particular surgical procedures.
    Ask a Question
    K Number
    K101805
    Device Name
    HYDROFIX VASO SHIELD
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2011-04-08

    (284 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIMEDX GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydroFix Vaso Shield™ is indicated for use as a cover for vessels following anterior vertebral surgery.
    Device Description
    The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is a slippery, clear pliable, conformable, nanoporous provided in valled over that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
    Ask a Question
    K Number
    K101826
    Device Name
    HYDROFIX VASO SHIELD, MODEL HVS-001-0610
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2010-07-28

    (27 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIMEDX GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K100905
    Device Name
    HYDROFIX SURGICAL SHEET
    Manufacturer
    MIMEDX GROUP, INC
    Date Cleared
    2010-06-02

    (62 days)

    Product Code
    OMR
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIMEDX GROUP, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
    Device Description
    The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
    Ask a Question

    Page 1 of 1