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510(k) Data Aggregation

    K Number
    K063133
    Device Name
    CRANIAL SOLUTION ORTHOSIS
    Manufacturer
    Date Cleared
    2007-07-02

    (262 days)

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

    CRANIAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cranial Solutions Orthosis is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly,including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.
    Device Description
    The CSO is a custom made medical device intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve symmetry and or shape. The device is of thermoplastic construct. A semi-rigid outer shell of Orthopedic grade copolymer polypropylene thermobonded to a medium durometer polyethylene foam inner liner(Volara). The formula for the outer shell is [ch(ch3)ch2-] 90% polypropylene and 10% polyethylene. By design the CSO is a dynamic orthotic device.
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