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Integra MOZAIK™ Osteoconductive Scaffold - Strip is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremittes, spine, and pelvis not intrinsic to the stability of the bony structure. Integra MOZAIK™ Osteoconductive Scaffold - Strip is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), Integra MOZAIKTM Osteoconductive Scaffold - Strip is resorbed and replaced with bone during the healing process.

The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is a porous resorbable bone void filler made from highly purified bovine Type I collagen and calcium salt (8-Tricalcium phosphate Ca3(PO4)2 per ASTM F1088). The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip bone grafting construct is designed to facilitate the repair of bony defects. The matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The three dimensional pore structure quickly imbibes fluids, making it easy to combine bone marrow aspirate. The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip guides bone regeneration across a critical defect site into which the products are implanted. New bone forms in apposition to the matrix surface when the grafts are placed in direct contact with viable host bone. Ultimately, the matrices are resorbed and remodeled into bone. The 5cc Integra MOZAIK™ Osteoconductive Scaffold - Strip is provided sterile, nonpyrogenic, for single use in double peel packages.

Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.

The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter (Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Camino Advanced Monitor (510(k) K962928 Integra LifeSciences Corporation). The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Integra Camino Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter. The following Accessories are referenced in 510(k) K904883: Drill, Drill Stop, Set Screw, Hex Wrench, Trocar, Trocar Sheath, Suture Loops, and Male Luer Cap. The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation. The Integra Camino Flex Adapter performs the functions of receiving the transducer signal from the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter, amplifying the signal, and transmitting the signal to the Camino® Advanced Monitor. The Integra Camino Flex Adapter converts the signals produced by the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter sensor. This signal is sent to the Adapter by means of the extension cable to the Camino® Advanced Monitor.