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    K Number
    K101616
    Device Name
    THE GRAPPLR AND GRAPPLR EXTENDER
    Manufacturer
    TAG MEDICAL CORP.
    Date Cleared
    2011-01-06

    (211 days)

    Product Code
    MBI, HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAG MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GrappLR™ and GrappLR™ Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament of tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
    Device Description
    The GrappLR™ suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The GrappLR™ has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture. The GrappLR Extender™ is a single-use, titanium implant used for providing additional button width and length to the GrappLR™
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