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510(k) Data Aggregation
K Number
K080259Device Name
JMEA CANNULATED BONE SCREW SYSTEM
Manufacturer
Date Cleared
2008-08-20
(202 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
JMEA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The JMEA cannulated bone screws are used to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.
Device Description
The titanium alloy screw is cylindrical with a tapered tip and has smooth single or double belix thread design. The JMEA cannulated bone screws are and to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in various lengths and diamsters, resulting in a screw design adapted to the graft norphology and patication anatomy.
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