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510(k) Data Aggregation

    K Number
    K160791
    Device Name
    AmorChem Titanium Porous Fixation Device
    Manufacturer
    AmorChem Holdings, Inc.
    Date Cleared
    2016-11-15

    (237 days)

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

    AmorChem Holdings, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AmorChem 3.8 mm Headless Porous Titanium Compression Screw is used for fixation of bone fractures, bone reconstruction, and fixation of osteotomies.
    Device Description
    The AmorChem Porous Titanium Fixation Device is a 3.8mm, 15mm long variable pitch, fully threaded, cannulated, and headless compression screw. The AmorChem screw is designed to be inserted into a pre-drilled hole that can be guided with a standard k-wire or Allen-drive k-wire. The headless design is intended to be seated flush with the surface of bone. The device is 40% titanium with interconnected porosity. The AmorChem device is provided clean, not sterile, and is single-use only.
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