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510(k) Data Aggregation

    K Number
    K013719
    Device Name
    BECKER BAND CRANIAL REMOLDING ORTHOSIS
    Manufacturer
    BECKER ORTHOPEDIC APPLIANCE CO.
    Date Cleared
    2002-02-05

    (89 days)

    Product Code
    MVA
    Regulation Number
    882.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECKER ORTHOPEDIC APPLIANCE CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
    Device Description
    The BeckerBand™ is a thermoplastic helmet prepared with USP Class VI materials, consisting of a polypropylene or polypropylene-polyethylene copolymer outer shell. To this shell is thermobonded a medium density polyethylene foam inner lining. The device is fabricated by taking a plaster-of-paris impression of the infants head. This impression is filled with a plaster to create a positive mold of the skull. The deformity is corrected to the desired configuration by building the mold up in selected areas with molding material. This corrected model serves as a template for preparation of the Becker Band orthosis. The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions.
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