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510(k) Data Aggregation
K Number
K173556Device Name
Injection Screw
Manufacturer
Date Cleared
2018-07-13
(238 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Biedermann Medtech, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.
Device Description
Miami Device Solutions (MDS) Injection Screws enable fixation of simple and complex fractures of the humerus. The MDS Injection Screws are only to be used in combination with compatible MDS 3.5T plating systems in the humerus (Proximal Humerus Plating System, K141493/K161058; MDS Plating System, K172786). When inserted through a 3.5T plate screw hole, injection screw placement is possible at any angle within a 40° cone. MDS Injection Screws can be used with or without bone void fillers. Fenestrations along the screw length allow bone void filler delivery directly into the surgical site.
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