LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K972760
    Device Name
    LINK, ACETABULAR REVISION MESH CUP
    Manufacturer
    LINK AMERICA, INC.
    Date Cleared
    1997-10-22

    (90 days)

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

    LINK AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:
    Device Description
    Link Acetabular Mesh Cup and Sheet
    Ask a Question
    K Number
    K964458
    Device Name
    ELLIS EXTERNAL MINI-FIXATOR SYSTEM
    Manufacturer
    LINK AMERICA, INC.
    Date Cleared
    1996-12-09

    (32 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINK AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955296
    Device Name
    LINK MP RECONSTRUCTION HIP
    Manufacturer
    LINK AMERICA, INC.
    Date Cleared
    1996-02-14

    (90 days)

    Product Code
    JDI, LWJ, LZO
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINK AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954186
    Device Name
    SLED UNICOMPARTMENT KNEE SYSTEM
    Manufacturer
    LINK AMERICA, INC.
    Date Cleared
    1996-01-26

    (142 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINK AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1