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510(k) Data Aggregation
K Number
K990019Device Name
DRG MEDIUM SCREW SYSTEM
Manufacturer
Date Cleared
1999-03-15
(70 days)
Product Code
Regulation Number
888.3040Why 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.
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K Number
K973810Device Name
DRG LARGE SCREW SYSTEM
Manufacturer
Date Cleared
1998-01-05
(90 days)
Product Code
Regulation Number
888.3040Why 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.
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