LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K964953
    Device Name
    IN-TAC BONE ANCHOR SYSTEM
    Manufacturer
    INFLUENCE, INC.
    Date Cleared
    1997-02-13

    (70 days)

    Product Code
    HXJ
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    HXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System consists of two components: a bone anchor, and a bone anchor inserter The In-Tac Bone Anchor System has the same overall design and technological characteristics as the configuration cleared under K962372, but implements the following changes: (1) the sutures will be provided pre-threaded for user convenience, and the retractable anchor shield will be incorporated into the disposable anchor assembly; (2) the inserter will be made from a stronger grade of stainless steel; and (3) the inserter incorporates a force measuring spring to ensure the anchors are deployed only if sufficient insertion force is applied.
    Ask a Question
    K Number
    K962372
    Device Name
    UROTAC BONE ANCHOR INSERTER
    Manufacturer
    INFLUENCE, INC.
    Date Cleared
    1996-08-19

    (61 days)

    Product Code
    HXJ
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    HXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.
    Device Description
    Consisting of: UroTac Bone Anchor Device for soft tissue to bone attachment. UroTac Bone Anchor Inserter Instrument used to insert bone anchor in desired situs.
    Ask a Question

    Page 1 of 1