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510(k) Data Aggregation
K Number
K200226Device Name
RetroFix
Manufacturer
Date Cleared
2020-06-26
(148 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Retrofix Screws, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RetroFix screw is a cannulated tapered screw intended to be used as stand-alone bone screw for internal bone fixation for bone fractures of the ankle.
Device Description
The RetroFix screw is a cannulated tapered screw intended to be used as a stand-alone bone screw for internal bone fixation for bone fractures of the ankle. The screw shaft has a predetermined length with a cannula extending through the length of the shaft. The shaft has a relatively large outside diameter proximal segment, a smaller outside diameter threaded distal segment, and a flared end. The proximal segment and the distal segment are unitary. The cannula is adapted for use with a surgical K-wire. The screws have cortical threads and come in many different sizes, varying in diameter and lengths. The device does not come sterile and must be sterilized prior to use.
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