CLEVELAND, June 20 /PRNewswire/ -- RSB Spine, LLC, a privately held medical device company focused on developing innovative spinal implants, today announced the U. S. Food and Drug Administration has conditionally approved its 510(k) application to permit marketing of the InterPlate(TM) GC Vertebral Body Replacement System.
Fusion is one of the most common spinal procedures performed by neurosurgeons and orthopedic spine surgeons. The InterPlate is a unique implant designed to facilitate rapid fusion and is used in conjunction with graft material to fuse two or more spinal vertebrae together. The InterPlate GC differs from the original InterPlate design in that it features an enclosed chamber to contain particulate graft material. Regulatory submissions covering cervical and lumbar interbody indications for both InterPlate designs will be submitted in July.
John A. Redmond, Chief Executive Officer, said, “We have reached another milestone in the InterPlate platform development program. As we continue to build distribution, the InterPlate GC will expand the options our distributors can provide surgeons. This device will be particularly attractive to users from a cost and time perspective, because a single device replaces the plate and spacer surgeons would typically employ.”
Mark J. Cwikla, M.D., a neurosurgeon from Irving, Texas, who performs over 400 spinal procedures a year and a current user of the InterPlate, said, “I have seen the new InterPlate GC, and I am excited about the benefits it will offer over existing devices. Whenever you can reduce the time it takes to implant a device, it is a benefit to both the patient and the surgeon. I look forward to trying this product.”
In 2004, RSB Spine sold its surgical instrument line to Jarit, an Integra Lifesciences Holding Corp. company, and in 2005 sold its cervical plate system to NuVasive, Inc.
RSB Spine, LLC
CONTACT: John A. Redmond, Chief Executive Officer, RSB Spine, LLC,+1-216-241-2804
