FDA 510(k) For TransCorp Spine’s SpinePort™ Cervical Minimally-Invasive Access and Visualisation System

In short

TransCorp Spine has announced that it received FDA 510(k) clearance for its SpinePort™ Spinal Access System. The SpinePort System provides direct access and visualisation to aid surgeons in treating cervical spine pathologies through a transcorporeal microdecompression procedure. The SpinePort System can also be used to harvest local autograft bone, eliminating the need for a second incision during cervical fusion procedures.

Background

TransCorp Spine is an innovative early-stage, medical device company dedicated to developing minimally-invasive, tissue-saving products and procedures for the treatment of cervical spine pathologies. TransCorp Spine products are designed to enable the surgeon to rapidaly, safely and effectively decompress the cervical spine without the need to perform a discectomy, fusion or arthroplasty offering patients an early return to life activities.

Since its initial market introduction in 2011, the SpinePort System has been approved for sale at world-class medical institutions and used by industry-leading spine surgeons across the United States. TransCorp Spine will continue to focus its efforts on expanding the use of the SpinePort System as it continues to commercialize its portfolio of products.

Company comments

“The clearance of the SpinePort System is an important milestone for TransCorp Spine, surgeons and patients in delivering the benefits of a minimally-invasive, motion-sparing cervical spine procedure,”said Christopher Welch, President and CEO of TransCorp Spine. “It is the first of several products that TransCorp Spine is developing to provide surgeons and patients with an alternative to traditional cervical fusion procedures,” he continued.

Source: Transcorp Spine Inc., PR Web