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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?
    Applicant Name (Manufacturer) :

    PARALLAX MEDICAL, INC.

    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
    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?
    Applicant Name (Manufacturer) :

    PARALLAX MEDICAL, INC.

    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
    K022169
    Device Name
    CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
    Manufacturer
    PARALLAX MEDICAL, INC.
    Date Cleared
    2002-07-25

    (22 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARALLAX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.
    Device Description
    The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm). The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include: - . 10cc VacLok syringe - Luer cap . - 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) . The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.
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    K Number
    K011206
    Device Name
    PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
    Manufacturer
    PARALLAX MEDICAL, INC.
    Date Cleared
    2001-07-18

    (90 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARALLAX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994022
    Device Name
    PARALLAX CRANIOSET
    Manufacturer
    PARALLAX MEDICAL, INC.
    Date Cleared
    2000-08-31

    (279 days)

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

    PARALLAX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Parallax Cranioset is a resinous material for repair of cranial defects.
    Device Description
    Parallax Cranioset is a resinous material for repair of cranial defects.
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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?
    Applicant Name (Manufacturer) :

    PARALLAX MEDICAL, INC.

    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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