FDA Gives 510(k) Clearance of ClearShield Implant Using Novel REVOX Sterilization Process
Little Falls, NJ - Cantel Medical Corp. and OsteoSymbionics, a leading designer and manufacturer of innovative, patient-specific craniofacial implants, are pleased to announce FDA (U.S. Food and Drug Administration) 510(k) clearance of OsteoSymbionics' signature ClearShield™ product made from Polymethyl methacrylate (PMMA). ClearShield™ is the first Class II medical device cleared by the FDA utilizing REVOX® Sterilization Solutions' room temperature peracetic acid/hydrogen peroxide (PAA) vacuum vapor sterilization process. ClearShield™ implants are used in patients who have suffered trauma to the skull, restoring the protective and cosmetic features of the individual's own bone.
Dorothy Baunach, CEO of OsteoSymbionics says, "REVOX® is the perfect solution for the sterile processing of our ClearShield™ craniofacial implants. More and more hospitals are discontinuing on-site use of ethylene oxide (EtO) sterilization and we needed a solution that would offer fast contract service turnaround and potential for processing at our manufacturing site as well. After much research into sterile processing options we discovered REVOX®, with the right technology and all the resources we needed to help our small, but well-respected company, work toward this ideal solution."
Jorgen Hansen, COO of Cantel Medical comments, "We are pleased that REVOX®Sterilization Solutions is able to facilitate the use of this innovative and critically important device. With increasing sophistication of medical, diagnostic, drug delivery, and implantable devices, REVOX is a timely alternative for manufacturers such as OsteoSymbionics. This 510(k) clearance underscores the safety and efficacy of the REVOX sterilization process and more broadly, our new product and market expansion capabilities within Cantel." Continue>
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