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NuVasive receives expanded FDA 510(k) clearance for magnetic, limb lengthening system

October 12, 2017

The FDA has granted NuVasive expanded 510(k) clearance for the Precice system from NuVasive Specialized Orthopedics. The expanded indications now include open and closed fracture fixation, treatment for pseudarthrosis, malunions and nonunions, and bone transport.

According to a company press release, prior to the expanded clearance, the Precice system was indicated for limb lengthening of the femur and tibia. In addition to limb lengthening, the system is now indicated for bone transport of long bones, which allows for regeneration of bony tissue and is used to fill segmental bone loss due to trauma or infection.

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