Search Results

The DC Ulnar Shortening System provides fixation for osteotomies of the ulna.

The DC Ulnar Shortening System is an implant intended for fixation of the ulna to assist healing. The implant is fabricated from titanium alloy. It is fixated with 3.5mm fixation screws and a 3.5mm self drilling self tapping headless interfragmentary screw. In addition to the plate and screws, there are instruments intended to assist with the procedure.

The provided text describes a 510(k) summary for the "DC Ulnar Shortening System", a metallic bone fixation appliance. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on:

• Device identification: Trade name, common name, classification, and submitter details.
• Predicate device comparison: Stating that the device is substantially equivalent to previously cleared ulnar osteotomy bone plates and screws.
• Device description: Materials (titanium alloy Ti6Al4V), function (fixation for osteotomies of the ulna), and components (plate, 3.5mm fixation screws, 3.5mm self-drilling self-tapping headless interfragmentary screw, instruments).
• Intended Use: Fixation for osteotomies of the ulna.
• FDA clearance letter: Affirming substantial equivalence based on the provided information.

Based on the provided text, I cannot complete the requested tables and information. The submission appears to be a "traditional" 510(k) that relies on substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the answer in the requested format as the necessary information is absent from the input.

Ask a specific question about this device