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510(k) Data Aggregation

    K Number
    K113297
    Device Name
    KNOTILUS ANCHOR SYSTEM
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Date Cleared
    2012-03-02

    (115 days)

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

    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Knotilus™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
    Device Description
    The Knotilus Anchor System consists of: • Knotilus Anchor - an implantable anchor preloaded on a disposable inserter to aid with anchor insertion into the bone. The Knotilus Anchor will be offered in outer diameters ranging from 3.5 mm to 6.0 mm and length ranging from 10 mm to 20 mm. • Knotilus Implant Loop - A non-absorbable UHMWPE (Dyneema) loop designed for fixation of soft tissue without the need of knot tying. The Knotilus Implant Loop will be offered with a total length of 470 mm and distal loop sizes of 22 mm, 25 mm and 28 mm. The Knotilus Anchor and Knotilus Implant Loop will be provided separately, sterile for single use only.
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    K Number
    K112296
    Device Name
    LATERAL BUTTON
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Date Cleared
    2011-12-01

    (114 days)

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

    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lateral Button™ is intended to protect the suture/bone during transosseous fixation procedures.
    Device Description
    The Lateral Button™ consists of an implanted Button preloaded on a disposable inserter necessary for its insertion into the bone tunnel, the inserter is removed upon completion of the procedure. The implant is made of implantable grade PEEK (polyether - etherketone). The inserter is made of Polycarbonate. The Lateral Button and its inserter will be supplied sterile for single use. The implant has an O.D. of 3.1 mm, overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded through the implant, which helps to distribute the pressure created by the suture and assists in the prevention of suture migration and damage to suture and/or bone. The implant will be supplied either as a stand alone device or as part of a kit i.e. with other devices already cleared for transosseous fixation procedures.
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    K Number
    K110763
    Device Name
    LATARJET CORTICAL SCREW SET
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
    Date Cleared
    2011-04-11

    (24 days)

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

    T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
    Device Description
    The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 20mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use.
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