ORTHOPAEDIC AND REHABILITATION DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Nov 4, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg Md.
CONTACT: Ronald Jean, 301-796-5650
The committee will discuss, make recommendations and vote on a premarket approval application for the Dynesys Spinal System, sponsored by Zimmer Holdings Inc. The Dynesys Spinal System is indicated to provide spinal alignment and stabilization in skeletally mature patients at one or two contiguous levels from L1S1.
All eyes will be watching as this meeting comes after the FDA said that they want to see clinical data for all “dynamic stabilization systems” intended to provide support to the spine during fusion
The FDA will make background materials available to the public no later than two business days before the meeting on its Web site... http://sww.fda.gov/AdvisoryCommittees/Calendar/default.htm
Orthopedics This Week… http://ow.ly/tGFC...
