FDA approves Custom Spine's anterior cervical interbody device

Custom Spine announced today that it has received FDA clearance to market PATHWAY ACIF, an anterior cervical interbody spacer.  This cervical interbody device compliments the company's low-profile anterior cervical plate system, Regent ACP, which was released this past November.

PATHWAY ACIF, with its large footprint, was designed to provide structural support in the disc space while allowing for a generous amount of autograft containment to promote fusion.  The spacer is manufactured from PEEK-OPTIMA®, a biocompatible, radiolucent material, and is available in both parallel and lordotic profiles with a wide range of heights.  

In addition, Custom Spine developed the system's instrumentation to facilitate ease of interbody implantation for the surgeon.  The system's dual ended trial feelers and the toggle free interface between the implant and inserter provide the surgeon with system versatility and controlled implantation.  "We are excited to continue the expansion of our cervical product line with the addition of PATHWAY ACIF.  As a company, we are dedicated to developing implants and instruments that create added benefits for both the patient and surgeon," commented Lew Bennett, President.

Source:

Custom Spine

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