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The Absorbable Cranial Flap Fixation System is intended to be used for fixation of cranial bone flaps following craniotomy.

The Absorbable Cranial Flap Fixation System is comprised of a lower disc, an upper disc, a connecting rod and a rotating lock. The lower disc consists of a circular disk through which the connecting rod is centrally extruded outward. The upper disc consists of a circular disk with a threaded hole to accept the connecting rod. The upper disc is driven to move axially along the connecting rod by rotating the rotating lock so that the discs tightly grip the bone flap and provide rigid attachment and coplanar alignment to the surrounding bone. The Absorbable Cranial Flap Fixation System is made from poly-L-lactic acid. The device is supplied sterile and is intended for single use. The Heat/Contouring Pen is an accessory used to cut off the excess connecting rod of the Absorbable Cranial Flap Fixation System. The Heat/Contouring Pen is a disposable, lithium battery powered handheld device that includes a cutting heating head and a smoothing head. The Heat/Contouring Pen is supplied sterile and is intended for single use.