Aesculap Implant Systems, Inc. Receives FDA 510(k) Clearance for the A-Fix™ (SIBD) Spinal System
CENTER VALLEY, Pa.–(BUSINESS WIRE)–The Aesculap Implant Systems A-Fix Spinal System received 510(k) clearance under K100802 by the U.S. Food and Drug Administration (FDA) on July 20, 2010. The A-Fix Spinal System is a stand-alone interbody fusion device developed for the anterior surgical approach and is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease with up to Grade 1 spondylolisthesis at the involved level(s).
About Aesculap Implant Systems, LLC
Aesculap was founded in 1867 in Tuttlingen, Germany and has grown into the largest and one of the most respected manufacturers of surgical instruments in the world. Over the years, Aesculap has continued to evolve into a diversified healthcare corporation by focusing its expertise in the areas of orthopaedics, spinal implants, neurosurgery and vascular systems and sutures.
In order to be more responsive to its growing customer base in spine and orthopaedics, Aesculap, Inc. formed a new company, Aesculap Implant Systems, LLC. This new company will focus on these unique markets allowing for greater innovation and customer service. Aesculap Implant Systems maintains a surgeon/patient focus with the goal of improved operative procedures and patient outcomes leading to an improved quality of life. For more information about Aesculap Implant Systems or its medical products, call 800-234-9179, email us atinfo@aesculap.com or visit www.AesculapImplantSystems.com.
About B. Braun
Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance both patient and health-professional safety. Its 30,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. For more information about B. Braun or its safety healthcare products, call 800-854-6851, email us at inquiry@bbraun.com or visit www.bbraunusa.com.
