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The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Biomet Microfixation Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone. The subject submission seeks to add the 2.1 x 255mm Drill, 22mm Stop to the Lorenz Twist Drills family to be used in neurosurgical procedures. 2.1 x 255mm Drill, 22mm Stop manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterile, to be sterilized by the end-user prior to use.

The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Biomet Microfixation Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years, but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities. The Pectus Blu Support Bar and Stabilizers are made of titanium alloy (ASTM F136) and provided nonsterile for sterilization by the end user.

The RibFix Advantage System is indicated for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The RibFix Advantage System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium (per ASTM F67) and titanium alloys (Ti-6A1-7Nb per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants: - . Titanium alloy RibFix Advantage Bridge with threaded locking posts - . Commercially pure titanium locking caps - . Commercially pure titanium washers (optional) When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. Washers may be placed on the posts prior to assembling with locking caps. The combined threaded locking post/locking cap provides for fixation of the bridge. The devices are sold non-sterile and intended to be sterilized by the user prior to implantation. The system also includes reusable instrumentation to aid in implantation of the devices.