MRI Safety information for:
COALESCE THORACOLUMBAR INTERBODY FUSION SYSTEM
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Polymeric spinal interbody fusion cage
In accordance with ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, NuVasive Inc.’s Coalesce Thoracolumbar Interbody Fusion System is labeled MR Conditional, following analysis comparing Coalesce Thoracolumbar Interbody interbody devices to nonclinically testing MR Conditional devices. Non-clinical testing has demonstrated that the Coalesce devices are MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions: