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510(k) Data Aggregation
K Number
K221362Device Name
Omni Foot and Ankle Plating System
Manufacturer
Date Cleared
2022-06-10
(30 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Exremity Medical, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Omni Foot and Ankle Plating System is internal fixation of arthrodesis, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
Device Description
The Omni Foot and Ankle Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths, thickness and number of holes. A locking compression slot is included in the plate to allow use of a locking screw for additional compression if desired by the surgeon. The locking and non-locking plate screws are provided in diameters of 2.3mm, 2.8mm and 3.5mm in lengths ranging from 6mm to 50mm. The System offers 3.5mm headed and headless cannulated screws and 4.0mm solid screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screws can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization. The Omni Foot and Ankle Plating System includes general use and system-specific instrumentation, such as drill bits, drill sleeves and drill guides, depth gauges, targeting guide, drivers, guidewires, and rasps. The system also includes a system-specific sterilization tray.
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