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Instrument Kit: Fractured Abutment/ Screw USA
The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw.T-Handle 5mmSocket M9Guide Pin RescueDrill Bit HolderDrill / Torx GuideAllen Key 2.5 mm
Details
Device typeInternal-external leg prosthesis osseointegration bar: A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration).
FDA categoryOsseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
Device ID07340152102027
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information