Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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

Notified Body Expert Akra Calls For Special Taskforce Measures To Oversee New COVID-19 Products

With many non-CE marked products being allowed onto various EU member state markets, who is going to monitor compliance? TÜV-SÜD’s Bassil Akra calls for cooperation to avoid unsafe products being used on patients.

India Keeps Door Ajar For Hydroxychloroquine Exports, Drug Makers Geared Up

Indian drug makers appear confident of meeting both domestic and global requirements for hydroxychloroquine sulphate after India relaxed export curbs on the product, subject to strict monitoring, against the backdrop of requests from global heads of government for supplies of the potential treatment for COVID-19.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts