Devices Orthopaedic Neurosurgery FDA

 News Release - September 20, 2007

RSB Spine, LLC Announces FDA Clearance of New InterPlate(TM) Indications

CLEVELAND, Sept. 20 (HSMN NewsFeed) -- RSB Spine, LLC, today announced the U.S. Food and Drug Administration has cleared the cervical and lumbar InterPlate(TM) devices for use in intervertebral fusion procedures. Included are versions to be used with solid bone grafts and morselized bone, without the need for supplemental fixation.

Fusion is one of the most common spinal procedures performed by neurosurgeons and orthopedic spine surgeons. The InterPlate is designed to facilitate rapid fusion and is used in conjunction with graft material to fuse spinal vertebrae together. Previously the InterPlate had only been approved for use as a vertebral body replacement in the thoraco-lumbar spine.

John A. Redmond, Chief Executive Officer, said, "We are pleased that the InterPlate is one of the first systems cleared by FDA since interbody fusion devices were reclassified on July 12. Now that cervical indications are available the platform can realize its full potential. This greatly expands the options our growing distribution network can provide surgeons."

James M. Moran, Chief Technical Officer, added "We feel the design of the InterPlate combines all the advantages of existing plates and interbody devices, without any of the disadvantages. Once the PEEK (polyetheretherketone) version of the InterPlate is approved in the first quarter of 2008 it will provide surgeons with a unique new option, not currently available from any other company."

RSB Spine is a privately held medical device company focused on developing innovative spinal implants. 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.

Source: RSB Spine

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