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6 important government approvals for your practice

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Spine Surgery Today has highlighted six stories of drugs and devices receiving government approval to keep your practice up-to-date.

Captiva Spine receives FDA clearance for TowerLOX MIS pedicle screw system

Captiva Spine announced it has received 510(k) clearance from the FDA to market its enhanced TowerLOX MIS Pedicle Screw System, which includes the patent-pending PivoQuik Rod Inserter and Tower Guide, to offer surgeons simple and quick rod alignment and placement, according to a press release. Read more.

First FDA cervical multilevel indication issued to Centinel Spine

Centinel Spine Inc. has been granted the first cervical multilevel indication for a Stand-Alone interbody device by the FDA. Read more.

Implanet receives FDA clearance and CE mark for new Jazz rods

Implanet, a medical technology company specializing in vertebral and knee-surgery implants, recently announced it has obtained regulatory clearance from the FDA, as well as the CE mark in Europe, to market its 3.5-mm, 4-mm, 4.5-mm and 6-mm Jazz rods in the United States, adding to the original 5.5-mm diameter clearance obtained in late April, according to a company release. Read more.

FDA approves Senza Spinal Cord Stimulation System

The FDA recently announced the premarket approval of Nevro Corporation’s Senza Spinal Cord Stimulation System. The new system can now begin commercial distribution, according to a letter from the FDA to the company. Read more.

Medtech receives marketing authorization in Australia for robotic surgery system

Medtech recently announced it has received official authorization to market its ROSA robot in Australia for minimally invasive surgical procedures on the brain, as well as for spine surgery. Read more.

Ellipse Technologies receives FDA clearance for external remote control

Ellipse Technologies recently announced it has received 510(k) clearance from the FDA to market its next-generation external remote controller for use with the Magnetic Expansion Control Spinal Bracing and Distraction System. Read more.