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510(k) Data Aggregation
K Number
K051017Device Name
R-X-FIX EXTERNAL FIXATOR
Manufacturer
R-X-FIX
Date Cleared
2005-06-29
(69 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
R-X-FIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The R-X-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies.
Device Description
The R-X-Fix External Fixator is a stable solution for fractures and for lengthening of small bones. The R-X-Fix External Fixator is hinged to allow adjustment in horizontal or vertical axis and is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The hinge system allows range of motion at the joint during treatment. The design allows the placement of pins to be adjusted around three orthogonal axes and translated linearly.
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