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Medical Devices / Submissions and Approvals

Tenex Gains FDA Clearance for Bone Remover

May 14, 2019

The FDA granted Tenex 510(k) clearance for its TX-Bone, a device used for clearing away calcific tissue and pain-causing bone.

The minimally invasive device is used through a small incision and a simple, ultrasound or palpation guided technique to selectively cut and debride tissue or bone using ultrasonic energy.

The device is able to treat soft tissue but was designed to efficiently remove painful bone spurs and osteophyte formations and calcific tissue.

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