Precision Spine Receives FDA Clearance for Anterior Cervical Plate System

Precision Spine has announced its subsidiary, Spinal USA, has received FDA clearance for a new anterior cervical plate system, according to a news release.

 

The Slimplicity solo anterior cervical plate system is comprised of one and two level plates and 4.5mm fixed and variable screws, and provides an ergonomic color coded instrument set, according to the company. It is designed to have a locking mechanism that accommodates visual locking confirmation.

 

The system is intended for anterior cervical fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

 

"The hours we've devoted to product research and development is producing great results," said Rich Dickerson, president of Precision Spine, in the release. "With Slimplicity solo, we have our third product launch in two years. This product will provide surgeons with an exciting new fixation system for the cervical spine, offering potential benefits over existing, traditional cervical plating systems. We also believe this product will have application in the expanding same day surgery market segment."

 

Spinal USA is headquartered in Pearl, Miss.

 

Related Articles on FDA Clearances:

Preventice Receives FDA Clearance for Remote Monitoring System

Siemens Receives FDA Clearance for Digital Radiography System

OptiMedica Receives FDA Clearance for Corneal Incisions With Catalys System

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