Research & Development
STERIBITE wins US FDA clearance for Steribite Disposable Kerrison Rongeur used in spine procedures
14 November 2018 -

Medical device company STERIBITE LLC reported on Tuesday the receipt of US FDA 510(k) clearance to market its first patented Steribite Disposable Kerrison Rongeur for the removal of bones on all spine procedures.

The company said the Kerrison rongeurs are instruments used to remove bone on all spine procedures and are critical in one of the stages of the operation; however reusable Kerrison rongeurs are difficult to clean, raising the risk of possible infection to the patients.

In addition, the reusable Kerrison rongeurs are expensive and difficult to maintain, which is frustrating for spine surgeons and increases the risk for patients.

STERIBITE LLC is a privately held medical device company and was developed by RJR Surgical Inc, a Cleveland, Ohio based company.

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