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510(k) Data Aggregation

    K Number
    K070130
    Device Name
    ORBITAL RECONSTRUCTIVE IMPLANT
    Manufacturer
    BECKER & ASSOCIATES CONSULTING INC
    Date Cleared
    2007-04-19

    (93 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BECKER **& ASSOCIATES CONSULTING INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.
    Device Description
    The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.
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    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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