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510(k) Data Aggregation

    K Number
    K111609
    Device Name
    BOSTON BAND
    Manufacturer
    BOSTON BRACE INTL., INC.
    Date Cleared
    2011-08-22

    (74 days)

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

    BOSTON BRACE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
    Device Description
    The Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to eighteen months of age. This condition is clinically known as Positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces to improve proportion and symmetry. The Boston Band is only available if prescribed by a physician. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The Boston Band is essentially the same device as released by K072862. It is an orthosis designed for each patient from a cast or scan of the infant's head. The mold, either plaster from a cast, or foam, carved from the scan, is modified and prepared for fabrication according to the instructions provided by the treating practitioner using plaster/CAD modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, a single layer of ½ inch or 5-6 layers of 1/8 inch, or a combination of 1 - 2 1/4 inch layers with 1/8 inch layers of hypoallergenic polyethylene foam (Aliplast/Plastazote) and a strap for securing the orthosis. It has a top and side opening. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
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    K Number
    K072862
    Device Name
    BOSTON-BAND CRANIAL REMODLING ORTHOSIS
    Manufacturer
    BOSTON BRACE INTL., INC.
    Date Cleared
    2008-01-22

    (109 days)

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

    BOSTON BRACE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boston Band Cranial Molding Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.
    Device Description
    The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician. The orthosis is custom designed for each patient from a cast of the infant's head , a scan using the STARscanner from Orthomerica, or a scan from the Hand held FastScan Handheld Laser Scanner. The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathernatical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
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    K Number
    K063098
    Device Name
    STATIC CRANIOPLASTY ORTHOSIS
    Manufacturer
    BOSTON BRACE INTL., INC.
    Date Cleared
    2007-04-11

    (183 days)

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

    BOSTON BRACE INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infants. 3 - 18 months of age, with abnormally shaped craniums with no outstanding cranial abnormalities that have a RX from a physician who has assessed the child to rule out craniosynostosis.
    Device Description
    The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattenedareas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician. The orthosis is custom designed for each patient from a cast of the infant's head or a scan using the STARscanner from Orthomerica . The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
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