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Mighty Oak Medical receives FDA clearance for pedicle screw navigation guide

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Mighty Oak Medical recently announced it has received FDA 510(k) clearance for its 3-D printed, patient-specific FIREFLY pedicle screw navigation guide.

The FIREFLY technology incorporates surgeon-defined parameters for the screw diameter, medial line angle and entry point into the patient-specific guides, which reportedly allow for optimal implant placement. As some tasks, such as implant sizing, are determined preoperatively instead of intraoperatively, use of the system can reportedly enhance quality of care and cost-savings in the OR. According to a company press release, the guides can be used with multiple pedicle screw systems.

Reference:

www.mightyoakmedical.com