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OrthoLogic

This article was originally published in The Gray Sheet

Executive Summary

FDA requests additional information regarding firm's premarket approval application for the OrthoLogic 1000B device, to be used in treating non-union fractures. No deficiencies were noted at FDA's November 1992 good manufacturing practices inspection for the PMA, which was filed in November 1991. The Phoenix, Arizona firm also is conducting clinicals of the device for delayed-union fractures (patients who are between five and nine months post-injury) and open comminuted tibial fractures. In addition, OrthoLogic has recently initiated trials of SpinaLogic 1000 for adjunctive use in spinal fusion therapy.
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