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

UsernamePublicRestriction
UsernamePublicRestriction

ACROMED BRANTIGAN SPINAL FIXATION CAGE/VSP PEDICLE SCREW COMBO NOT APPROVABLE DUE TO MATERIAL AND DESIGN CHANGES, PANEL CONCLUDES

This article was originally published in The Gray Sheet

Executive Summary

Acromed's premarket approval application for the Brantigan interbody spinal fusion cage with VSP pedicle plate/screw system is not approvable because of post-PMA submission modifications in device design and material composition, FDA's Orthopedic and Rehabilitation Devices Advisory Panel decided by a 7-1 vote at its Dec. 11 meeting in Bethesda, Maryland.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT009242

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

Cancel