Custom Spine Receives 510k Clearance Of Regent ACP

Main Category: Bones / Orthopaedics
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 06 Nov 2009 - 2:00 PST

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Regent ACP, Custom Spine's anterior cervical plate system, has received 510k Clearance from the U.S. Food and Drug Administration (FDA). This product 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.

"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, CA, November 10th - 14th.

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.

Source: Custom Spine