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Spinal Simplicity issued FDA clearance for interlaminar fusion device

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Spinal Simplicity recently announced the FDA has granted 510(k) marketing clearance for the company’s Minuteman system.

The Minuteman is a pre-packaged, sterile, supplemental posterior fixation system that offers a minimally invasive alternative to traditional pedicle screws and other spinous process plates that are placed in open procedures for the treatment of degenerative disc disease, spondylolisthesis, tumors and/or trauma, according to a company press release.

The system can be placed utilizing either a posterior unilateral or a lateral percutaneous approach, known as PercLIF (Percutaneous Lateral Interlaminal Fusion).

With the PercLIF surgical approach to the spine, direct lateral surgeons will now have the ability to insert a supplemental posterior fixation device with the patient remaining in the lateral decubitous position, according to the release.

The company anticipates commercial launch of the Minuteman system in the first quarter of 2015.

Reference: www.spinalsimplicity.com.