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510(k) Data Aggregation

    K Number
    K023575
    Device Name
    CONCERT CRANIOPLAST
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2003-01-22

    (90 days)

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

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Concert™ Cranioplast is a resinous material for repair of cranial defects.
    Device Description
    Concert™ Cranioplast is a resinous material for repair of cranial defects.
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    K Number
    K013755
    Device Name
    CONCERT RADIOPAQUE BONE CEMENT
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2002-02-08

    (87 days)

    Product Code
    LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
    Device Description
    Not Found
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    K Number
    K003205
    Device Name
    TRANSFX ANGLED RODS
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2000-12-15

    (63 days)

    Product Code
    LXT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fractures.
    Device Description
    TransFx Angled Rods
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    K Number
    K001228
    Device Name
    EXTERNAL FIXATION ANCHOR PIN
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2000-07-07

    (81 days)

    Product Code
    JDW
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001084
    Device Name
    TRANS FX ADJUSTABLE PIN TO BAR CLAMP
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2000-06-15

    (72 days)

    Product Code
    LXT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991723
    Device Name
    TRANSFX MULTI PIN CLAMP
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    1999-07-22

    (63 days)

    Product Code
    LXT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary Exation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.
    Device Description
    TransFx Multi-Pin Clamp
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    K Number
    K990848
    Device Name
    TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    1999-05-17

    (63 days)

    Product Code
    LXT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.
    Device Description
    TransFx Small External Fixation System, TransFx Intermediate External Fixation System, TransFx Mini External Fixation System
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    K Number
    K984357
    Device Name
    TRANSFX EXTERNAL FIXATION SYSTEM
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    1999-03-04

    (87 days)

    Product Code
    LXT, JDW, KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMEDICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture
    Device Description
    TransFx External Fixation System
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