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510(k) Data Aggregation
K Number
K954856Device Name
CANNULATED FEMORAL NAIL
Manufacturer
SYNTHES (USA)
Date Cleared
1996-03-08
(137 days)
Product Code
JDN
Regulation Number
888.3060Why did this record match?
Product Code :
JDN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures.
Device Description
Synthes CFN is a cannulated locking intramedullary fixation device. It is cannulated throughout the length of the nail which facilitates insection over a guide rod into a reamed or unreamed femur. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The most proximal locking hole is elongated. Nail accessories include a Twisted Blade, 5.0 mm Shaft Screws, Locking Sleeves, 4.9 mm Locking Bolts, and End Caps. The accessories are intended to transmit load between the bone and the CFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures. The device is manufactured from titanium alloy.
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