Regulatory Actions
RSB Spine Announces Another 510(k) Approval for the InterPlate Vertebral Body Replacement Implant System
Published in Drug Law Weekly, May 8th, 2007
RSB Spine, LLC, a privately held medical device company focused on developing innovative spinal implants, announced that the U.S. Food and Drug Administration has approved its 510(k) application to permit marketing of the InterPlate(TM) Vertebral Body Replacement System for use without supplemental fixation. The new indication will allow RSB Spine to market the product as an anterior fusion device, without the need for additional posterior implant support. Submissions for cervical and lumbar interbody indications will follow, as well as new product designs based on the InterPlate platform.
The InterPlate(TM) VBR is a unique spinal implant designed to facilitate rapid...
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Source: Drug Law Weekly (2007-05-08)
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