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510(k) Data Aggregation
K Number
K153211Device Name
M-Fix Acromioclavicular Device
Manufacturer
Date Cleared
2016-02-02
(89 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
CORACOID SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The M-Fix™ Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Device Description
The M-Fix™ Acromioclavicular Device (M-Fix™) is a suture band system designed to provide reduction and stabilization of the acromioclavicular joint following syndesmotic disruptions. The M-Fix is a polyethylene terephthalate (PET) band that may be tensioned and secured with the integrated, low-profile Connector/Button which is made of titanium or stainless steel.
The one-time use band with connector is provided sterile. Additional accessory instruments, including a Counter Traction Tool and a Punch Tool for securing the Connector/Button are single use devices provided sterile for use during the orthopedic procedure.
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