Custom Spine Receives 510(k) Clearance of Regent ACP

Custom Spine featured its Regent ACP anterior cervical plate system, which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks the latest addition to Custom Spine’s continually expanding product line.

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.

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.

Custom Spine is a privately held company headquartered in Parsippany, N.J.