Spine

Custom Spine Receives FDA Clearance for PATHWAY ACIF

PARSIPPANY, N.J., March 24 /PRNewswire/ — 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.

About Custom Spine

Custom Spine, Inc. is a pioneering leader in the spine market creating the next generation of surgeon-friendly spinal implants and instruments that provide superior performance and patient care.  The company was founded by top engineers and industry professionals in partnership with orthopedic and neurological spine surgeons to develop advanced medical solutions.  Custom Spine (www.customspine.com) is a privately held company headquartered in Parsippany, New Jersey.  For more information, please contact 1-973-808-0019.

SOURCE Custom Spine

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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