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    K Number
    K133668
    Device Name
    AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
    Manufacturer
    SHOULDER OPTIONS, INC.
    Date Cleared
    2014-03-03

    (94 days)

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

    SHOULDER OPTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
    Device Description
    The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.
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    K Number
    K121672
    Device Name
    AFT PROXIMAL HUMERUS FRACTURE PLATE
    Manufacturer
    SHOULDER OPTIONS, INC.
    Date Cleared
    2012-10-01

    (117 days)

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

    SHOULDER OPTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
    Device Description
    The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.
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    K Number
    K102539
    Device Name
    ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
    Manufacturer
    SHOULDER OPTIONS, INC.
    Date Cleared
    2011-02-24

    (174 days)

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

    SHOULDER OPTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cuff Repair Plate™ is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.
    Device Description
    The Cuff Repair Plate (CRP) is a fixable suture anchor plate that is designed to improve anchorage-to-bone strength during rotator cuff tendon-to-bone repair. When assembled, the device consists of a contoured, D-shaped buttress bone plate that is coupled to two anchor bolts. The plate is available in both right and left configurations. Anchor bolts are available in various lengths. Both the plate and the anchor bolts are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use. The CRP is for use with #2 or #5 polyethylene-based high-strength non-absorbable braided suture.
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