RSB Spine, a medical device company developing spinal implants with a focus on modular fusion products, has received FDA approval for its 510(k) application to market its 'InterPlate' C-PS and L-PS Interbody Spacers.
The InterPlate System is a spinal implant designed to facilitate the process and is used in conjunction with graft material to fuse two or more spinal vertebrae together.
John Redmond, chief executive officer of RSB Spine, said: “We are excited about this new clearance, since it gives our distributors two additional products to offer customers seeking greater options in Zero-Profile technologies. Our InterPlate portfolio now provides surgeons with the most unique implant combinations on the market.”
Robert Bray, director of St Johns Spine Institute in Santa monica, California, and inventor of the InterPlate, said: “The InterPlate is a device incorporating the best features of plate and interbody designs without the drawbacks. I believe its design and features will appeal to spine surgeons and that it will soon become the implant of choice for single-level spinal fusion.”
Mike Neill, president of Paradigm BioDevices, said: “Zero-Profile technologies comprise one of the growing segments in the spinal industry. RSB Spine is the company with a full-line modular interbody platform offering a complete array of material and mechanical loading options that is also code compliant.”