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The IMTEC Bone Tac System is designed to stabilize a Barrier Membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.

The IMTEC Bone Tac is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization. It is designed to stabilize guided tissue membranes during the healing process by providing an attachment mechanism to the adjacent bone at the surgical site. The device will be marketed non-sterile.

This document (K973180) is a 510(k) premarket notification for the IMTEC Bone Tac. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) is a submission to the FDA demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and indications for use, rather than presenting new performance data from clinical studies with specific acceptance criteria. This submission focuses on the description of the device and its comparison to predicate devices already on the market.

Therefore, I cannot provide the requested information based on the provided text. The document primarily describes the device, its intended use, and its similarities to existing products, which is the core of a 510(k) submission for substantial equivalence.

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