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510(k) Data Aggregation

    K Number
    K061934
    Device Name
    XTAC
    Manufacturer
    OSTEOGENICS, INC.
    Date Cleared
    2007-07-17

    (375 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XTAC is indicated for the temporary bridging of fascial defects where primary closure is not possible, including, but not limited to, abdominal compartment syndrome.
    Device Description
    Not Found
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    K Number
    K983753
    Device Name
    STAR TEMPORARY WOUND COVER
    Manufacturer
    OSTEOGENICS, INC.
    Date Cleared
    1999-11-18

    (398 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary.
    Device Description
    Not Found
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    K Number
    K964537
    Device Name
    BONESOURCE HYDROXYAPATITE CEMENT (HAC)
    Manufacturer
    OSTEOGENICS, INC.
    Date Cleared
    1997-01-24

    (73 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm per defect.
    Device Description
    The Osteogenics BoneSource® Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement that hardens in an aqueous environment at body temperature and consists solely of calcium phosphate compounds. The cement is mixed freshly at the time of implantation and can be applied directly into the defect to fill the void. BoneSource® remains malleable for approximately 20 minutes during which time it can be contoured to custom-fit the defect. The setting reaction is complete after four hours. BoneSource® is fabricated by combining two phosphates of calcium (i.e., dicalcium phosphate and tetracalcium phosphate). At the time of use, BoneSource® is combined with sterile water which results in an isothermic setting reaction yielding pure HAC after four hours. Under in-vitro conditions (37°C), the product hardens in approximately 20 minutes. After four hours, the reaction is complete, yielding pure hydroxyapatite with no significant dimensional changes and no by-products. The compressive strength of BoneSource® is ≥ 50 MPa. The BoneSource® paste during the setting reaction has been determined to be in the range of 6.5 to 8.5. As a consequence of its apatitic nature, the product is highly compatible with both soft and hard tissue. Approximately 45% of the implant volume consists of micropores (the remainder is solid) with an average pore size of <1 micron in diameter. This small pore diameter serves to inhibit the passage of infection-causing microorganisms. BoneSource® is supplied sterile and is intended for single use only.
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    K Number
    K953339
    Device Name
    BONESOURCE HYDROXYAPATITE CEMENT (HAC)
    Manufacturer
    OSTEOGENICS, INC.
    Date Cleared
    1996-06-27

    (346 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTEOGENICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osteogenics BoneSource™ Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2 per defect.
    Device Description
    The Osteogenics BoneSource™ Hydroxyapatite Cement (HAC) is a self-setting, calcium phosphate cement that hardens in an aqueous environment at body temperature and consists solely of calcium phosphate compounds. The cement is mixed freshly at the time of implantation and can be applied directly into the defect to fill the void. BoneSource™ remains malleable for approximately 20 minutes during which time it can be contoured to custom-fit the defect. The setting reaction is complete after four hours. BoneSource™ is fabricated by combining two phosphates of calcium (i.e., dicalcium phosphate and tetracalcium phosphate). At the time of use, BoneSource™ is combined with sterile water which results in an isothermic setting reaction yielding pure HAC after four hours. Under in-vitro conditions (37℃), the product hardens in approximately 20 minutes. After four hours, the reaction is complete, yielding pure hydroxyapatite with no significant dimensional changes and no by-products. The compressive strength of BoneSource™ is ≥ 50 MPa. The pH of the BoneSource™ paste during the setting reaction has been determined to be in the range of 6.5 to 8.5. As a consequence of its apatitic nature, the product is highly compatible with both soft and hard tissue. Approximately 45% of the implant volume consists of micropores (the remainder is solid) with an average pore size of < 6 microns in diameter. This small pore diameter serves to inhibit the passage of infection-causing microorganisms. BoneSource™ is supplied sterile and is intended for single use only.
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