Custom Spine, Incorporated (Custom Spine) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Regent ACP. The company claims that the Regent ACP is a low profile anterior cervical plate system that was designed with innovative self-locking slides to give the surgeon confidence of the plate being securely locked into place.
The system comes equipped with both fixed and variable angle screws allowing the construct to be rigid, semi-constrained or a combination of both to provide the surgeon with intra-operative versatility.
“As a company, we are committed to bringing innovative products to the spine market. This product further demonstrates this commitment as well as Custom Spine’s focus to expand our product offering”, commented Lew Bennett, President. “We believe the Regent anterior cervical plate system offers unique features to enhance confidence and patient well-being.”
The Regent ACP system includes a variety of instrumentation for implantation to provide treatment flexibility to the surgeon. These instruments include All-In-One-Guides as well as single- and double-barrel drill guides allowing the surgeon to select the best implantation method for the individual patient.
Regent ACP’s market introduction will be held next week during the North American Spine Society’s annual meeting in San Francisco, California, November 10th – 14th, 2009.