Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K990019
    Device Name
    DRG MEDIUM SCREW SYSTEM
    Date Cleared
    1999-03-15

    (70 days)

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

    DOLPHIN MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that care common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatassi, fibular shaft, malleolus fractures where indicated, The DRG Medium Screw™ System is indicated for: Humeral Shaft Distal and proximal humerus Distal and proximal radius and ulna Radial and ulna shaft Distal tibia and ankle Talus-calcaneus-matatarsal Fibular shaft and Malleolus fractures Intermediate Bone Fractures
    Device Description
    The Dolphin Medical Technologies DRG Medium Screw™ System will be offered in Ti-6A1-V ELI. It will be available in common styles and assorted lengths for bone fixation and stabilization. A range of twenty six screw lengths will be made available in 4.5 mm diameter (16-72 mm) with four different distal thread length dimension (6.5mm, 16mm, 26mm). The screws are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated, on center axis.
    Ask a Question

    Ask a specific question about this device

    K Number
    K973810
    Device Name
    DRG LARGE SCREW SYSTEM
    Date Cleared
    1998-01-05

    (90 days)

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

    DOLPHIN MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dolphin Medical Technologies DRG Large Screw™ System will be used on indications that are common with presently marketed devices. The indications for use of the DRG Large Screw™ System reconstruction of intra-anicular epiphyseal and of metaphyseal fractures. Specifically, intracapsular fractures of the hip, slipped capital femoral epiphyses, tibial plateau fractures, distal femoral condyle fractures, ankle, elbow and shoulder fractures where indicated.
    Device Description
    The DMT DRG Large Screw™ System will be offered in Ti-GAL-4V ELL It will be available in common styles and assorted lengths for bone fraction and stabilization. Initially, a range of twenty-four screw lengths will be made available in 6.5 mm diameter (25-120 mm). Screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwcriver, which is cannulated at center.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1