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510(k) Data Aggregation
K Number
K042437Device Name
DORSAL INTRAMEDULLARY PLATE
Manufacturer
DEO VOLENTE ORTHOPAEDICS, LLC
Date Cleared
2004-10-08
(30 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
DEO VOLENTE ORTHOPAEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The fixation of fractures and osteotomies involving the distal radius. This single use device is for cementless use only.
Device Description
This anatomically contoured plate system offers several sizes and styles of distal heads in either titanium (ASTM F-136) or stainless steel (ASTM F-138). The distal head of the plate contains two rows of two screw holes each that accept 2.7 mm screws. The distal row of screw holes are threaded allowing for fixed angle support of the fracture fragments utilizing the threaded head screws. The proximal row of screw holes has a spherical seat allowing for variability in screw angle fixation while still using the threaded head screws. The threaded head screws vary in length from 16mm to 26mm and are fully threaded. K-wires may also be used for stabilization of bone fragments. The device utilizes a press fit intramedullary fixation for the proximal stem when inserted into the radial intramedullary canal while the distal head is secured to the fracture fragment using the above described bone screws.
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