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510(k) Data Aggregation

    K Number
    K990436
    Device Name
    ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1999-03-31

    (48 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTiMAX™ brand Trochanteric Intramedullary Rod System is indicated for single use to stabilize intertrochanteric and subtrochanteric fractures of the proximal femur.
    Device Description
    ULTiMAX™ Trochanteric Intramedullary Rod System II
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    K Number
    K990481
    Device Name
    ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1999-03-17

    (29 days)

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

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.
    Device Description
    ULTIMAX™ Distal Radial (Volar) Locking Plate System
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    K Number
    K990513
    Device Name
    ULTIMAX CORTICAL BONE SCREWS
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1999-03-17

    (27 days)

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

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTiMAX™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI ULTiMAX™ Humeral Intramedullary Rod System.
    Device Description
    Not Found
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    K Number
    K981230
    Device Name
    ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1998-06-01

    (59 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTiMAX™ brand Distal Femoral Intramedullary Rod System is indicated for single use to stabilize distal femoral fractures, including supracondylar fractures, severely comminuted supracondylar fractures with difficult intra-articular extension, fractures that require stabilization of the femoral condylar segment, distal fractures in osteoporotic bone, pathologic fractures, pseudoarthrosis, malunions and failed distal femoral osteosynthesis.
    Device Description
    ULTiMAX™ Distal Femoral Intramedullary Rod System
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    K Number
    K980102
    Device Name
    BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1998-04-03

    (81 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BT™ Humeral Intramedullary Rod device is indicated for fractures of the humerus.
    Device Description
    BTI™ Humeral Intramedullary Rod System
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    K Number
    K974756
    Device Name
    BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1998-03-12

    (83 days)

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

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTI™ brand Large (7.0 mm) Cannulated Transfixing Screw is indicated for single use with the BTI brand Proximal Humeral Intramedullary Rod, the BTI brand Mid-Shaft Humeral Intramedullary Rod and the BTI brand Tod, the Britishedullary Rod Systems to stablifize fractures.
    Device Description
    Not Found
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    K Number
    K972403
    Device Name
    BTI CORTICAL BONE SCREWS
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1997-08-29

    (64 days)

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

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI Compression Hip Screw System, BTI Humeral Intramedullary Rod Systems, and the BTI Distal Femoral Intramedullary Rod System.
    Device Description
    Not Found
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    K Number
    K970897
    Device Name
    BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1997-04-21

    (41 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962706
    Device Name
    EZ-FIX CANNULATED SCREW SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1996-11-13

    (124 days)

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

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    indicated for single use to stabilize intracapsular, certain cervical and subcapital fractures of the femur; fractures of the distal femur and proximal tible: pelvis and acetabular fractures and certain fractures of the shoulder and elbow. They are contraindicated for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, lumbar spine.
    Device Description
    The EZ-Fix™ Cannulated Screws are fabricated from titanium allov (Ti-BAL-4V ELI). They are tested per ASTM standards and have a thread diameter and length of 7.3 mm and 20 mm respectively and a shaft diameter of 5.3 mm. They accept a 3.2 mm guide pin through the 3.45 mm cannulation. They are self reaming and tapping and have reverse cutting flutes. The EZ-Fix™ Cannulated Screws are available in 35 mm to 125 mm lengths are supplied non-sterile.
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    K Number
    K962987
    Device Name
    EZ-FIX SMALL CANNULATED SCREW SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1996-11-04

    (95 days)

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

    BIODYNAMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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