In Brief: U.S. Surgical
This article was originally published in The Gray Sheet
Executive SummaryU.S. Surgical: Receives approvable letter from FDA for its Ray threaded spinal fusion cage, the firm announces Sept. 6. The firm is working on final labeling for the degenerative disk disease treatment device. An FDA preapproval inspection of manufacturing facilities for the Ray has not yet been scheduled. FDA's Orthopedic and Rehabilitation Devices Advisory Panel recommended approval of the device in May ("The Gray Sheet" May 27, p. 5)...
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