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510(k) Data Aggregation
(84 days)
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
The Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate is a machined metal plate that is designed for fixation of various fracture modes of the distal portion of the radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius plate allows fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. Synthes' variable angle locking technology enhances plate-screw construct stability. The plates are manufactured in either titanium or stainless steel.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets them. This document appears to be a 510(k) summary for a medical device (Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate), which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies and acceptance criteria. The information provided is primarily regulatory in nature.
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