Alliance Medical Corporation Receives 510k Clearance for Diamond Drill Burs; First Reprocessor 510k Clearance Since SVS Conclusion.PHOENIX, Ariz. -- Alliance Medical Corporation (Alliance), a leading reprocessor of single-use medical devices (SUDs), today announced U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance of Alliance's reprocessed diamond bur drill bits. This marks the first 510(k) clearance by the FDA for a reprocessed device without the need for a supplemental validation submission (SVS SVS - OS/VS2 ) as directed by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA MDUFMA Medical Device User Fee and Modernization Act ). "Alliance commends the FDA for their continued dedication to ensuring patient safety and providing a safe and effective alternative to high-priced medical supplies," said Rick Ferreira, president of Alliance Medical Corporation. "The heightened review by the FDA is further evidence that reprocessed devices are at least as safe as other medical devices and enable Alliance to continue to provide desperately needed supply cost-savings for our hospital partners." "With this new 510(k) clearance Alliance has again demonstrated our commitment to meeting the FDA's requirements for reprocessed medical devices as we continue to grow our product under the FDA's extremely heightened oversight," added Don Selvey, vice president of Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: The new clearance covers models by Linvatec, MicroAire, Zimmer, Anspach and Stryker. These drill bits are used in surgery to cut and shape bones. The FDA's clearance to reprocess re·proc·ess tr.v. re·proc·essed, re·proc·ess·ing, re·proc·ess·es To cause to undergo special or additional processing before reuse. Verb 1. these drill bits allows Alliance Medical to provide greater savings opportunities for their hospital partners. Having safely reprocessed more than twelve million SUDs, Alliance is one of the industry's most trusted device reprocessing Reprocessing may refer to:
About Alliance Medical Corporation Alliance Medical Corporation (Alliance) is a leading reprocessor of specific single-use medical devices (SUDs) and has safely reprocessed more than 12 million SUDs, saving hospitals and surgery centers in excess of $150 million. Alliance goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading healthcare organizations. Alliance is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates which together ensure that we exceed our partners' goals and expectations. The company's services focus on reducing supply costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance has agreements with leading national group purchasing organizations, alliances and supply chain service firms, including VHA VHA Veterans Health Administration VHA Variable Housing Allowance VHA Villages Homeowners Association VHA Voluntary Hospitals Association VHA Virtual Home Agent VHA Very High Altitude VHA Vapor Hazard Area VHA Vermont Holstein-Friesian Association , Broadlane and University HealthSystem Consortium (UHC UHC UnitedHealthcare UHC United Health Care UHC University Hospitals of Cleveland UHC United Hitech Corporation UHC Udvar-Hazy Center (National Air and Space Museum) UHC University Health/System Consortium UHC Unburned Hydrocarbons ), as well as a number of nationally recognized hospital integrated delivery networks, including Banner Health Banner Health is a non profit health system based in Phoenix, Arizona. The health system is one of the largest employer’s in the state - employing over 27,000 employees. and Henry Ford Health System that collectively represents more than 4,000 healthcare facilities. For more information about Alliance Medical Corporation, visit www.alliance-medical.com; or call 888-888-3433. |
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