Neo Medical Spinal Tumor Device Wins 510(k) Clearance and CE Mark

June 18, 2021

Neo Medical announced that it has received both a CE mark and FDA 510(k) clearance for its Neo Pedicle Screw System, which is used in surgery for late-stage spinal tumors.

The new CE mark extends the system’s existing certification to include 8-millimeter screws, iliac screws and connectors, as well as rod-to-rod connectors.

The 510(k) marketing clearance is for use of the system in combination with BonOs Inject cement from Osartis, in cases where the structural integrity of the spine is not severely compromised.

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