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510(k) Data Aggregation

    K Number
    K222799
    Device Name
    Haymaker® Screw System
    Date Cleared
    2023-01-10

    (116 days)

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

    OrthoCircle Spine d.b.a. OC Medical Devices

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
    Device Description
    The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.
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