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The Synthes (USA) Curvilinear Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus where gradual bone distraction is required. This system is intended for use in either adults or pediatric patients over 1 year old. The Synthes (USA) Curvilinear Distraction System is intended for single use only.

The Synthes Curvilinear Distractor is an internal distraction osteogenesis device that gradually advances the mandible along a specific path of distraction. The system features various curved and straight distractors which are fixed to the mandible with bone screws. The distractors accept extension arms which move the point of activation to a location that is easily accessible with the activation instrument.

I am sorry, but based on the provided text, there is no information about specific acceptance criteria, study details demonstrating device performance against those criteria, sample sizes, expert involvement, or any form of comparative effectiveness or standalone studies.

The document is a 510(k) summary for a medical device (Synthes (USA) Curvilinear Distraction System) that focuses on demonstrating substantial equivalence to predicate devices. It outlines the device description, intended use, and confirms it has been reviewed and found substantially equivalent by the FDA.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and performance studies. This type of information is typically found in performance testing reports, clinical study summaries, or validation reports, which are not included in this 510(k) summary.

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