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510(k) Data Aggregation

    K Number
    K030031
    Device Name
    SOFT TISSUE ANCHORING WASHERS
    Manufacturer
    ACCU-SPEED, INCORPORATED
    Date Cleared
    2003-01-28

    (25 days)

    Product Code
    KGS
    Regulation Number
    878.4930
    Why did this record match?
    Product Code :

    KGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.
    Device Description
    Soft Tissue Anchoring Washers [washers], [washer, bolt nut]
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    K Number
    K020480
    Device Name
    RBM
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2002-03-12

    (27 days)

    Product Code
    KGS, GAT
    Regulation Number
    878.4930
    Why did this record match?
    Product Code :

    KGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair. The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.
    Device Description
    The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.
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    K Number
    K964935
    Device Name
    SUTURE LOCK
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY, INC.
    Date Cleared
    1997-02-25

    (77 days)

    Product Code
    KGS
    Regulation Number
    878.4930
    Why did this record match?
    Product Code :

    KGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures. The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair procedures.
    Device Description
    The Suture Lock is a sterile, single-use device manufactured from polyacetal.
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