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510(k) Data Aggregation

    K Number
    K033230
    Device Name
    TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
    Manufacturer
    PARALLAX MEDICAL, INC.
    Date Cleared
    2003-12-12

    (67 days)

    Product Code
    MYU
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    MYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRACERS® Ta Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin to provide radiopacity for imaging purposes.
    Device Description
    TRACERS® Ta Bone Cement Opacifier is an additive to be used with Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of the implant material. The TRACERS® Ta Bone Cement Opacifier is added to the Secour polymer (powder) prior to mixing with the Secour monomer (liquid). TRACERS Bone Cement Opacifier is comprised of USP Barium Sulfate and unalloyed Tantalum disks.
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    K Number
    K032388
    Device Name
    BONE CEMENT RADIO-OPACIFIER
    Manufacturer
    Cardinal Health
    Date Cleared
    2003-10-31

    (88 days)

    Product Code
    MYU
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    MYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used as an additive to Codman Cranioplastic (Type 1-slow set) to provide radiopacity for imaging purposes.
    Device Description
    The Bone Cement Radio-Opacifier is an additive to be used with Codman Cranioplastic (K873689) to provide radiopacity to the resin and assist in placement and visualization of material.
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    K Number
    K024359
    Device Name
    VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
    Manufacturer
    VISTA SCIENTIFIC, LLC
    Date Cleared
    2003-08-08

    (221 days)

    Product Code
    MYU
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    MYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vista Scientific Barium Sulfate™ is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.
    Device Description
    Vista Scientific Barium Sulfate is a dry powder supplied sterile and non-pyrogenic for use as a radiopacifying additive to Codman Cranioplastic™ (Type 1-Slow set) bone cement. The Barium Sulfate is supplied in a quantity of 6 grams, packaged in a closed 120 mL polymer container, and sealed within a double sterile peel pouch package configuration.
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    K Number
    K023445
    Device Name
    TRACERS BONE CEMENT OPACIFIER
    Manufacturer
    PARALLAX MEDICAL, INC.
    Date Cleared
    2003-03-11

    (147 days)

    Product Code
    MYU
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    MYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRACERS® Bone Cement Opacifier is intended for use as an additive to Secour™ Acrylic Resin or Codman Cranioplastic™ (Type I -- Slow Set) to provide radiopacity for imaging purposes.
    Device Description
    TRACERS Bone Cement Opacifier is an additive to be used with Codman Cranioplastic (K8736989) or Secour Acrylic Resin (K994022) to provide radiopacity to the resin and assist in placement and visualization of material. The TRACERS Bone Cement Opacifier is added to the Cranioplastic or Secour monomer (powder) prior to mixing with the Cranioplastic or Secour polymer (liquid). The end product (Cranioplastic or Secour and Tracer particles) is substantially equivalent to Cranioplastic and Secour alone.
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    K Number
    K002063
    Device Name
    BIOTRACE, MODEL 1730
    Manufacturer
    BRYAN CORP.
    Date Cleared
    2000-08-10

    (34 days)

    Product Code
    MYU
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    MYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991893
    Device Name
    PARALLAX TRACER RADIOPAQUE PARTICLES
    Manufacturer
    PARALLAX MEDICAL, INC.
    Date Cleared
    1999-08-13

    (71 days)

    Product Code
    MYU
    Regulation Number
    882.5300
    Why did this record match?
    Product Code :

    MYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 - Slow Set) to provide radiopacity for imaging purposes.
    Device Description
    Parallax™ Tracer Radiopaque Particles
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