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510(k) Data Aggregation

    K Number
    K250613
    Device Name
    SnapHammer Hammertoe Correction System
    Manufacturer
    Nvision Biomedical Technologies Inc
    Date Cleared
    2025-04-02

    (33 days)

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

    Nvision Biomedical Technologies Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
    Device Description
    The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.
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