Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

FDA To Accept Wright’s PMA Amendment For Augment Bone Graft

This article was originally published in The Gray Sheet

Executive Summary

The agency has agreed to accept Wright Medical’s PMA amendment for its embattled Augment bone graft, saving the firm from going to a dispute resolution panel this spring.

You may also be interested in...



Orthopedics Earnings Roundup

Financial earnings reports from Smith & Nephew, Wright Medical, Zimmer, Stryker and Orthofix.

Wright Moves More To Extremes With Tornier Purchase Agreement

The all-stock transaction valued at around $3.3 billion will create a device and biologics company with a comprehensive focus on orthopedic extremities surgery. The firms expect cost synergies of $40 to $45 million.

FzioMed Oxiplex Dispute Panel Postponed So CDRH Can Review More Data

With more data submitted to CDRH, FzioMed and the device center have agreed to postpone a planned June 10 dispute-resolution panel meeting on the firm’s previously rejected PMA for the Oxiplex spine surgery gel.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032828

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel