Ascent Healthcare Receives 510(k) Clearance on Zimmer TransFx External Fixation Devices.PHOENIX -- Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the 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. ) has cleared Ascent's 510(k) 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. Zimmer TransFx[TM] External Fixation external fixation n. The fixation of a fractured bone by a splint or plastic dressing. external fixation Orthopedics Open reduction, stabilization and use of external fixators to manage fracture bone fragments devices. Ascent has the most extensive list of FDA-cleared reprocessed external fixation devices originally manufactured by industry leaders including Synthes, Smith & Nephew, Stryker Trauma and DePuy Orthopedics (a Johnson & Johnson company). External fixation devices are used to stabilize selected bone fractures. The modular Zimmer TransFx System provides options in frame construction, simplicity in frame components and ease of transition from one frame size to another. Ascent has clearance to reprocess the intermediate and large rods and clamps that are part of the TransFx system. Ascent will not reprocess the pins that are inserted into bone. "Hospitals throughout the U.S. are striving to improve patient care and environmental stewardship The integration and application of environmental values into the military mission in order to sustain readiness, improve quality of life, strengthen civil relations, and preserve valuable natural resources. while seeking prudent solutions to address rising supply costs," stated Rick Ferreira, Ascent's chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . "Reprocessing Reprocessing may refer to:
Safety and effectiveness testing during validation included statistically substantiating the mechanical properties of the reprocessed Zimmer TransFx external fixation devices. All devices passed static and dynamic mechanical testing methods, which included cycling devices at a predetermined pre·de·ter·mine v. pre·de·ter·mined, pre·de·ter·min·ing, pre·de·ter·mines v.tr. 1. To determine, decide, or establish in advance: value and ensuring that no sample failed prior to completion. Unlike original equipment manufacturers that only test a sample of the devices they manufacture, Ascent's technicians and quality control inspectors examine and test every device at multiple points during reprocessing to ensure they will perform as intended. They reject any device that does not pass every inspection and test. Ascent Healthcare Solutions and its predecessor companies have safely reprocessed more than 50 million single-use medical devices for over 1,700 healthcare facilities nationwide, including a majority of U.S. News & World Report U.S. News & World Report Weekly newsmagazine published in Washington, D.C. U.S. News was founded in 1933 by David Lawrence (1888–1973) to cover important domestic events; he founded World Report in 1945 to treat world news. The two magazines were merged in 1948. "Honor Roll honor roll n. A list of names of people worthy of honor, especially: a. A list of students who have earned high grades during a specified period. b. A list of people who have served in the armed forces. " hospitals. In 2006, the company will save hospitals more than $90 million in supply expenses. About Ascent Healthcare Solutions Ascent Healthcare Solutions, the leading independent third-party reprocessor of single-use medical devices (SUDs), has reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. The company's primary reprocessing center and home office are in Phoenix, Ariz. with an additional reprocessing center in Lakeland, Fla. Ascent holds agreements with all leading national group purchasing organizations as well as numerous nationally recognized hospital integrated delivery networks that collectively represent more than 5,000 healthcare facilities. For more information about Ascent Healthcare Solutions, visit www.ascenths.com. |
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