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The Synthes Combination Clamp with Dynamization Clip is generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for: - stabilization of soft tissue injuries and open or closed fractures; . - polytrauma; . - vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic . fractures: - arthrodesis and osteotomies with soft tissue problems; . - failures of total joints; ● - neutralization of fractures stabilized with limited internal fixation; ● - . non-unions/septic non-unions; - intraoperative reduction/stabilization tool to assist with indirect reduction; . - unilateral rectilinear bone segment transport or leg lengthening; ●

The Synthes Combination Clamp and Dynamization Clip attaches the Schanz screws (pins) to an 11 mm rod or tube, or two rod/tubes together. It consists of two spring compressed opposing vise plates that are interlocked to a one piece self contained clamp. The Dynamization clip is inserted into the clamp to allow dynamization. The device is manufactured from a Titanium Alloy and Stainless Steel.

This document is a 510(k) summary for a medical device called the "Synthes Combination Clamp and Dynamization Clip." It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

Medical device summaries of this type (510(k) Pre-Market Notifications) are primarily focused on demonstrating substantial equivalence to a predicate device already on the market, rather than presenting detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text because it is not present in this type of regulatory submission.

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