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510(k) Data Aggregation

    K Number
    K173693
    Device Name
    Orbitum Bone Staple Implant, X and VI
    Date Cleared
    2018-02-23

    (84 days)

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

    Orthovestments, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
    Device Description
    Orbitum Bone Staple Implants, X and VI, have either radial or hourglass shaped superior profiles in three distinct sizes to coincide with the surgical approach. The legs of the device are configured to create compression upon implantation. Orbitum Bone Staple Implants , are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
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