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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSECURE-C ARTIFICIAL CERVICAL DISC
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, PA 19403
PMA NumberP100003
Date Received01/29/2010
Decision Date09/28/2012
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 12M-1039
Notice Date 10/02/2012
Advisory Committee Orthopedic
Clinical Trials NCT00882661
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE SECURE-C ARTIFICIAL CERVICAL DISC. THIS DEVICE IS INDICATED IN SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OFTHE DISC AT ONE LEVEL FROM C3-C7 FOLLOWING SINGLE- LEVEL DISCECTOMY FOR INTRACTABLE RADICULOPATHY (ARM PAIN AND/OR A NEUROLOGICAL DEFICIT) WITH OR WITHOUT NECK PAIN, OR MYELOPATHY DUE TO A SINGLE-LEVELABNORMALITY LOCALIZED TO THE DISC SPACE AND AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY RADIOGRAPHIC IMAGING (CT, MRI, X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR VISIBLE LOSS OF DISC HEIGHT AS COMPARED TO ADJACENT LEVELS. THE SECURE-C CERVICAL ARTIFICIAL DISC IS IMPLANTED USING AN ANTERIOR APPROACH. PATIENTS SHOULD HAVE FAILED AT LEAST 6 WEEKS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE SECURE-C CERVICAL ARTIFICIAL DISC.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 
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