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510(k) Data Aggregation

    K Number
    K151540
    Device Name
    MC BIO Supertack Tack 3mm, 4mm and 5mm
    Date Cleared
    2016-05-26

    (353 days)

    Product Code
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELI-KA TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MC Bio Supertack tacks are used for the stabilization of absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio Supertack system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. General patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use. The MC Bio Supertack tacks are used for the stabilization of absorbable and non-absorbable membranes during the bone tissue regeneration and bone repair in the maxillofacial or mandibular area. The MC Bio SUPERTACK system is designed to stabilize barrier membranes onto cortical plate bone, this may be used in maxillofacial or mandibular bone. Gnereral patient health, bone type and quality, and functional loads exerted should be considered and carefully evaluated prior to use.
    Device Description
    The MC Bio SUPERTACK System consists of 3mm, 4mm and 5mm bone tacks and associated instrumentation. The tacks material consist of Titanium alloy, as specified in ASTM F136 STANDARD for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy, anodized blue color. The devices are provided non-sterile.
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