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510(k) Data Aggregation

    K Number
    K030302
    Device Name
    HBS HEADLESS BONE SCREW
    Manufacturer
    SCHOENING & ASSOC., INC.
    Date Cleared
    2003-08-08

    (191 days)

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

    **SCHOENING **& ASSOC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Headless bone screw system for the fixation of osseous fragments or fractures including: HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures
    Device Description
    Not Found
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