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The NervAlign® Nerve Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity.

The NervAlign® Nerve Cuff is a collagen membrane matrix derived from porcine pericardium. It is a sterile, whitish to light beige colored, freeze-dried, pre-cut, flat sheet of acellular collagen. The NervAlign® Nerve Cuff is available in three (3) different sizes: 10x10mm, 20x30mm and 30x40mm. The collagen material that comprises the Nerve Cuff is derived from the same species as that of the predicate nerve cuff (AxoGuard Nerve Protector; K132660) manufactured by Cook Biotech Incorporated. Like the predicate, the NervAlign® Nerve Cuff is implanted providing a scaffold which becomes infiltrated by the patient's cells and is remodelled into native tissue. The Nerve Cuff provides protection of the damaged nerve while the nerve heals. The NervAlign® Nerve Cuff is packaged in a dried state, is for single use and provided sterile.