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IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.

The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.

IFS bone plates consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of Titanium 6Al-4V ELI or stainless steel.

This document is a 510(k) summary for Internal Fixation Systems, Inc.'s IFS Bone Plates, Screws, and Washers. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.

This document is a 510(k) premarket notification summary and does NOT contain information about acceptance criteria or a study proving device performance against such criteria. It's a regulatory submission to demonstrate equivalence to already-marketed devices, not a performance study report.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory equivalence rather than performance metrics.

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