Pinnacle Spine Group Wins FDA Approval for Direct Lateral System

The FDA has approved Pinnacle Spine Group’s patented InFill System for direct lateral spinal fusion procedures.

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The system includes the InFill Interbody Fusion Device and InFill Graft Delivery System. The InFill System includes lateral interbody fusion devices manufactured from PEEK-Optima. The implant is designed to provide a generous bone grafting area, with endplate contact surfaces that optimize the weight bearing properties of the cage. The Graft Delivery System is designed to facilitate controlled and precise placement of biologic material into the implanted device. Comprehensive instrumentation, including a retractor system, extensive disc and endplate preparation options and other instrumentation complete the system.

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