I)t '4- 37 2025

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The document is a premarket notification (510(k)) for the Synthes RIA System, an orthopedic surgical instrument intended for adults and adolescents to clear the medullary canal, harvest bone and marrow, and treat osteomyelitis. It outlines the device's classification, intended use, substantial equivalence to predicate devices, and supporting literature for its indications. The FDA has determined that the device is substantially equivalent to legally marketed devices, allowing it to be marketed under general controls.

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Click ‘Get Form’ to open I)t '4- 37 in the editor.
Begin by entering the date prepared in the designated field. Ensure accuracy as this is crucial for record-keeping.
Fill in the sponsor information, including the name and contact details of Angela F. Lassandro, ensuring all fields are complete.
In the device name section, input 'Synthes RIA System' as specified. This identifies the product clearly.
Complete the classification and product code fields with 'Class II, 21 CFR §888.4540' and 'HTO & HRX' respectively.
Provide a detailed description of the device, focusing on its components and intended use as outlined in the document.
Review all entries for accuracy before saving or exporting your completed form to ensure compliance with regulatory standards.

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