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Integra LifeSciences obtains FDA 510(k) approval for Integra laminoplasty system

Integra LifeSciences, an integrated medical technology company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Integra laminoplasty system, a comprehensive set of implants and instruments designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3).

Integra LifeSciences’ Integra system has various plate and screw options and allows surgeons to treat varying patient anatomies.

The system features multiple plate insertion and drill guide options, and a new retentive screw driver, ensuring a seamless approach to laminoplasty procedures.

Integra LifeSciences president of US Spine Kirt Stephenson noted the company is very pleased that it can now offer surgeons a comprehensive and easy-to-use treatment option for laminoplasty procedures.

"Our new Laminoplasty System should be a welcome addition to surgeons’ repertoire of spinal therapies," Stephenson added.

Spinal stenosis is treated by the laminoplasty procedures by relieving pressure on the spinal cord.

Integra LifeSciences will feature the Integra laminoplasty system at the North American Spine Society 28 annual meeting, from 9 October to 12 October 2013, in New Orleans, Louisiana.