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510(k) Data Aggregation
K Number
K032169Device Name
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
Manufacturer
Date Cleared
2003-09-22
(68 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
CYBERORTHOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.
Device Description
CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring). Part of external fixator aiding trophism in the correction of bone deformities/defects. Same physical design as predicate, except aesthetically and tactual more pleasing with improved impression of superior strength and safe mobility. Radiolucent Carbon Fiber Composite utilizing Randomly orientated, pre-impregnated carbon strands resulting in a carbon fiber content of better than 62%.
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