
[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Notices]
[Page 24426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09744]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0293]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    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 July 24 and 25, 2013, 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone 
number is 301-977-8900.
    Contact Person: Sara J. Anderson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, 301-796-7047, 
Sara.Anderson@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On July 24, 2013, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application for the Kineflex/C Cervical Artificial Disc 
sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt 
chrome molybdenum alloy) cervical total disc replacement device. The 
Kineflex/C is indicated for reconstruction of the intervertebral disc 
at one level from C3-C7 following single-level discectomy for 
intractable radiculopathy or myelopathy due to a single-level 
abnormality localized to the disc space.
    On July 25, 2013, the committee will discuss, make recommendations, 
and vote on information related to the premarket approval application 
for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The 
Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome 
molybdenum alloy) lumbar total disc replacement device. The Kineflex 
Lumbar Artificial Disc is indicated for reconstruction of the 
intervertebral disc at one level (L4-L5 or L5-S1) following single-
level discectomy for lumbar degenerative disc disease (DDD) where DDD 
is defined as discogenic back pain with degeneration of the disc as 
confirmed by patient history, physical examination, and radiographic 
studies.
    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. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before July 
15, 2013. Oral presentations from the public will be scheduled on July 
24 and 25, 2013, between approximately 11:30 a.m. and 12:30 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before July 
5, 2013. Time allotted for each presentation may be limited. If the 
number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by July 8, 2013.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams at 
Annmarie.Williams@fda.hhs.gov or 301-796-5966 at least 7 days in 
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-09744 Filed 4-24-13; 8:45 am]
BILLING CODE 4160-01-P


