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510(k) Data Aggregation
K Number
K051309Device Name
ROI FUSION RODS & PLATES
Manufacturer
REILEY ORTHOPAEDICS, INC.
Date Cleared
2005-07-11
(53 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
REILEY ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
Device Description
The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rods come in a variety of diameters and lengths. The plates are available in various widths, lengths and thicknesses. Both the rods and plates have fins to aid in resisting rotation or movement. The rods and plates are made from titanium alloy ((T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium. The bodies are plasma spray coated with commercially pure titanium
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