FDA grants NEMARIS spine surgery planning software 510(k) clearance

Spinal Tech

NEMARIS received 510(k) clearance from the U.S. Food and Drug Administration for the next-generation SURGIMAP 2.0 platform.

The software is used to preoperatively plan spine surgery, and the new iteration of the software offers advanced tools to determine and restore optimal spinal alignment for each patient. It also features case and image sharing across users through cloud services.

 

The platform includes the UNiD plug-in, which was jointly developed with MEDICREA, one of NEMARIS' strategic partners. The plug-in is embedded into the SURGIMAP 2.0 software interface and allows surgeons an efficient option for planning and ordering the UNiD rods — patient-specific spinal osteosynthesis rods currently available in Europe.


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