Search Results
Found 1 results
510(k) Data Aggregation
K Number
K141401Device Name
EASY OUT
Manufacturer
Date Cleared
2015-02-20
(268 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FEET FOR LIFE PODIATRY CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Easy Out™ system is indicated for temporary internal fixation of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
Device Description
Easy Out™ system consists of various, partially threaded solid screws designed to create lag compression used for temporary internal fixation small bones and fragments. The Easy Out™ bone screws are self-tapping, self-drilling screws with thread diameters of 2.0 mm, 2.5 mm, 3.0 mm, 3.5mm, 4.0 mm, and lengths that range from 12 mm to 60 mm. All compression screws are fabricated from medical grade titanium alloy (per ASTM F-136). Associated instrumentation is available. All compression screws are offered "non sterile".
Ask a Question
Ask a specific question about this device
Page 1 of 1