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...
You may also be interested in...
Tissue Debate Raises Fairness, Transparency Questions For Combo Products
CDRH's decision to require 510(k) submissions for demineralized bone matrix (DBM) products is at odds with previous policy statements by the Center for Biologics Evaluation & Research, the American Association of Tissue Banks maintains in comments sent to the FDA center directors April 19
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.