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Wright Medical Group

This article was originally published in The Gray Sheet

Executive Summary

Submission of a 510(k) application for the Arlington, Tennessee firm's Allomatrix products containing demineralized bone matrix is announced March 19. The submission responds to a recent "formal" notification from FDA, confirming a previous oral advisory that the products be regulated as medical devices, Wright says (1"The Gray Sheet" May 7, 2001, p. 17). No interruption in shipments is expected, according to Wright...

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