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510(k) Data Aggregation

    K Number
    K100721
    Device Name
    LOCKING BONE SCREW MODEL HCQ04, HCZ04
    Manufacturer
    CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD.
    Date Cleared
    2010-11-23

    (253 days)

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

    CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Locking Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
    Device Description
    The proposed device, Locking Bone Screw, is made of Titanium Alloy (6Al-4V ELI) that meets ASTM F136 - 08e1 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) which is intended to be used with Orthmed Locking Compressing Bone Plate for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
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