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The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
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Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. [2] Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; neurosurgical, neurovascular and spinal devices; as ...
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MAKO Surgical was founded in 2004 by Rony Abovitz and other key members of its predecessor Z-KAT, Inc. [9] Z-KAT was founded in 1997 by Rony Abovitz, William Tapia, Michael Peshkin Ph.D., Julio Santos-Munne, and Wayne J. Kerness, M.D. and was developing a novel haptic robotic system for medical applications, amongst a wide variety of computer-assisted surgery technologies.
Uniform Driver Interface, a project to develop portable device drivers; Unified Display Interface, digital video interface specification based on DVI; Universal Disk Image, a disk image format; Unique Device Identification, a system that is intended to assign a unique identifier to medical devices within the United States
It makes changes to medical device fees, including establishing a fee for a 30-day notice, a request for classification information, and periodic reporting for a class III device. It extends the authority of accredited people (third parties) to review premarket reports for devices and make recommendations to the FDA regarding the classification ...