Precision Spine Receives FDA Clearance for Minimally Invasive Access System

Precision Spine has announced it has received FDA clearance for a minimally invasive access system, according to a news release.

 

The Mini-Max minimally invasive access system is intended for use with the company's S-LOK pedicle screw system. The Mini-Max is design to enable spine surgeons to perform minimally invasive procedures using a "versatile 'access/fixation' system that has been designed to achieve results using a minimally disruptive procedure, that are the same as or better than those achieved using … open procedures," according to the company.

 

"We believe that the first phase launch of the Mini-Max minimally invasive access system represents a significant advancement in minimally invasive approaches to spine surgery," said Rich Dickerson, president of Precision Spine, in the release. "We are planning to make the system available in two phases. Phase 1, the base system, will enable pedicle screw-based tissue retraction and distraction for maximal access to the disc space. Phase 2, the additional system components, will enable parallel, bilateral distraction of vertebral bodies to facilitate even more effective placement of an advanced interbody device, which is now in the development phase. The company's commitment to research and product development continues to bear fruit with products such as the Mini-Max minimally invasive access system that offer unique advantages to surgeons, patients, hospitals and payers, and that are helping to differentiate us from our competition."

 

Precision Spine is headquartered in Parsippany, N.J.

 

Related Articles on FDA Clearances:

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