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Medical Devices / Submissions and Approvals

Alphatec’s Neuromonitoring Device Receives 510(k) Clearance

March 1, 2019

Alphatec received 510(k) clearance for its SafeOp neuromonitoring system, an automated device that is used to assess the health of a patient’s spinal cord and nerves.

The device, which is used in real-time to monitor a patient’s health during surgery, can also be used by surgeons to test nerves for conduction, location and proximity.

Using the system, a surgeon can monitor the health of nerves in a patient’s lumbar plexus while conducting a minimally invasive procedure.

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