FDA warns Allez Spine over design revisions to spinal screw

10/22/2008 | FDAnews

The FDA has issued a warning letter to Allez Spine saying that the firm made modifications to its Laguna Pedicle Screw System without filing a premarket application. Allez said it intends to introduce an updated version of the spinal fixation device and submit it to the agency for 510(k) clearance.

View Full Article in:

FDAnews

Published in Brief:

SmartBrief Job Listings for Health Care

Job Title Company Location
Counsel – Regulatory Affairs
RAI Services Company
Winston Salem, NC
Director of Program Development
AdvaMed
Washington DC, DC
Director of System QA
LifeWatch Services, Inc.
Rosemont, IL
Director of Business Development and Membership
AdvaMed
Washington DC, DC
Director, Corporate Counsel
Regeneron
Tarrytown, NY