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510(k) Data Aggregation

    K Number
    K140453
    Device Name
    OSTEOTEC SILICONE FINGER IMPLANT
    Manufacturer
    OSTEOTEC LTD
    Date Cleared
    2015-04-17

    (417 days)

    Product Code
    KYJ
    Regulation Number
    888.3230
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOTEC LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis.
    Device Description
    The OSTEOTEC Silicone Finger Implant is a single piece flexible joint replacement implant for the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joints in the hand; commonly due to rheumatoid arthritis or osteoarthritis. The one-piece device consists of a specifically designed, central, flexible hinge attached to an elongated rectangular-based pyramid stem on either side. The stems insert into the intramedullary canals of the metacarpals and/or phalanges and have a slight surface texture. The OSTEOTEC Silicone Finger Implant is manufactured from implant grade silicone. It is available in eleven, evenly scaled sizes to meet various anatomical requirements. The OSTEOTEC Silicone Finger Implant is not designed for use with any other devices. The implant has dedicated instrumentation which is required to prepare the bone for the implant and sizers to ensure that the correct size of product is used.
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