RSB Spine has received FDA Clearance for its InterPlate System as an interbody implant with an integrated fixation and anterior screw fixation, according to a company news release.
New FDA product codes for stand-alone interbody devices with integrated fixation:
• Lumbar interbody devices are OVD
• Cervical interbody devices are OVE
In addition to the new product codes, InterPlate retained code KWQ for anterior screw fixation in the spine.
"The InterPlate product line is a modular interbody platform and in that regard is different from other stand-alone implants," John Redmond, CEO of RSB, said in the release. "The new FDA codes and the retention of our KWQ code help to clarify this difference and provide surgeons with the advantages of a stand-alone implant and the ability to code as a typical anterior plate construct."
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• Lumbar interbody devices are OVD
• Cervical interbody devices are OVE
In addition to the new product codes, InterPlate retained code KWQ for anterior screw fixation in the spine.
"The InterPlate product line is a modular interbody platform and in that regard is different from other stand-alone implants," John Redmond, CEO of RSB, said in the release. "The new FDA codes and the retention of our KWQ code help to clarify this difference and provide surgeons with the advantages of a stand-alone implant and the ability to code as a typical anterior plate construct."
Related Articles on Spine Devices:
Infuse Sales Decline Drives Medtronic's 2Q Spinal Revenue Decrease
Global Spine Surgery Market to Reach $9.3B by 2017
X-spine Receives FDA Clearance for Spinal Implant System