FDA Dynesys Spinal System Nov 4, 2009

[Slackwater]

ref: http://www.fda.gov/AdvisoryCommittee.../ucm185494.htm

November 4, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting Announcement

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.


Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the
Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and
recommendations to the agency on FDA’s regulatory issues.
Date and Time: The meeting will be held on November 4, 2009, from
8 a.m. to 5 p.m.

Location: Holiday Inn, Walker/Whetstone Room, Two Montgomery Village
Ave., Gaithersburg, MD.


Agenda: On November 4, 2009, the committee will discuss, make
recommendations and vote on a premarket approval application for the
Dynesys Spinal System, sponsored by Zimmer Spine. The Dynesys Spinal
System is indicated to provide spinal alignment and stabilization in skeletally
mature patients at one or two contiguous levels from L1–S1.
FDA intends to make background material available to the public no later
than 2 business days before the meeting. If FDA is unable to post the
background material on its Web site prior to the meeting, the background
material will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA’s Web
site after the meeting.