SHOULDER, METAL/POLYMER ELBOW PROSTHESES AND PLASTER OF PARIS SHOULD GET CLASS II STATUS, WITH METAL/METAL ELBOWS REMAINING IN CLASS III -- ORTHOPEDIC PANEL
This article was originally published in The Gray Sheet
Executive SummaryShoulder and metal/polymer elbow prostheses should be downclassified to Class II, FDA's Orthopedic Devices Panel concluded at a Jan. 12 meeting in Gaithersburg, Maryland. However, the advisory committee recommended that metal/metal elbow prostheses remain in Class III, given a lack of data on the novel devices.
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