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510(k) Data Aggregation
K Number
K140158Device Name
S.E.A.L. FRACTURE FUSION TUBE
Manufacturer
Date Cleared
2014-05-29
(127 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
D.N.E., LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The S.E.A.L. Fracture Fusion Tube is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Device Description
The S.E.A.L. Fracture Fusion Tube provides a solution for fractures and for lengthening of small bones. The system allows controlled compression / distraction and early weight bearing. The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures or arthrodesis of the fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
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K Number
K113106Device Name
DNE EXTERNAL FIXATION SYSTEM
Manufacturer
Date Cleared
2012-01-04
(76 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
D.N.E., LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DNE External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The DNE External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Device Description
The DNE External Fixation System assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints. Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.
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