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FDA clears new patient-specific spinal rod

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The Medicrea Group announced it has received 510(k) clearance from the U.S. Food and Drug Administration for UNiD, a patient-specific spinal osteosynthesis rod.

The technology premiered earlier this month at the North American Spine Society Annual Meeting, according to a press release.

UNiD features a software tool to help surgeons preoperatively plan their surgeries and order customized, industrially produced rods to fit the specific spinal alignment needs of each patient, eliminating the need to manually contour a rod during surgery.

The UNiD rod system has been successfully implanted in more than 100 patients in Europe, according to the release.

Reference: www.medicrea.com