U.S. FDA Grants 510(k) Approval to Evonik's Implantable VESTAKEEP® PEEK Product Announces Modern Plastics, North American Distributor Spinal Implant Device Receives U.S. Food and Drug Administration's Approval for Use as an Intervertebral Body Fusion Device
SHELTON, Conn., Feb. 8, 2013 /PRNewswire/ -- A spinal implant device using Evonik's VESTAKEEP® PEEK (polyetheretherketone) has received the U.S. Food and Drug Administration's (FDA) 510(k) approval for use as an Intervertebral Body Fusion (IBF) device.
"This is an exciting and major development for the VESTAKEEP® PEEK product," said Bing J. Carbone, President of Modern Plastics, stocking distributor of VESTAKEEP® products.
"With 510(K) approval of the VESTAKEEP® PEEK product and inventory available in rod, resin and powder, Modern Plastics can provide technical support, fast shipping from stock inventory in Connecticut, USA, complete product traceability and detailed certification with every shipment. In addition, there are no contractual requirements, royalties or start-up fees to purchase the VESTAKEEP® PEEK from Modern Plastics," he added.
VESTAKEEP® PEEK is known for its superior biocompatibility and biostability. Its excellent sterilization resistance and good combination of stiffness and ductility make it suitable for medical implant applications that must meet extremely high mechanical, thermal, and chemical requirements.
For more information about or to purchase VESTAKEEP® PEEK products, please visit: www.modernplastics.com or contact Vince Griffin, Modern Plastics Medical Plastics Manager at 203.333.3128, extension 207 or e-mail firstname.lastname@example.org
Modern Plastics has been in business since 1945 and is headquartered in Shelton, Connecticut, USA. The company barcodes all of its plastic product for complete traceability, retains records for 20-years, is ISO 9001:2008 and ISO 13485:2003 certified and is a leading world-wide supplier of medical-grade plastic stock shapes. Modern Plastics, 88 Long Hill Cross Road, Shelton, Connecticut 06484 USA. Phone: 203.333.3128 Fax: 203.333.4625
Company President: Bing J. Carbone, e-mail: email@example.com
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SOURCE Modern Plastics