Resources for Food and Drug Administration (FDA)

BioMedical Enterprises receives FDA clearance on new device

www.bizjournals.com

The Food and Drug Administration (FDA) approved BioMedical Enterprises Inc.'s new spinal product to market.

The local company received FDA 510(k) marketing clearance for its OSSpine product for use in the anterior fixation of the cervical spine. The product is designed to provide enhanced biomechanical stability and bone graft retention.

The patent-pending OSSpine builds on the company's OSStaple, OSSplate and OSSArc products in the OSSforce Fixation System portfolio.

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