Spinal Simplicity's Minuteman system receives FDA 510(k) clearance

Spinal Tech

Spinal Simplicity received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Minuteman system.

The Minuteman is a pre-packaged sterile supplemental posterior fixation system, which offers a minimally invasive alternative to traditional pedicle screws and other spinous process plates that are placed in open procedures. It is indicated for the treatment of degenerative disc disease, spondylolisthesis, tumors or trauma. The system can be placed using two minimally invasive approaches — posterior unilateral or lateral percutaneous (PercLIF).

 

"One of the many potential benefits of the Minuteman system is 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, typically in about 10 to 15 minutes," said Todd Moseley, co-founder of Spinal Simplicity.

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