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Device | SECURE-C ARTIFICIAL CERVICAL DISC |
Generic Name | Prosthesis, intervertebral disc |
Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. AUDUBON, PA 19403 |
PMA Number | P100003 |
Date Received | 01/29/2010 |
Decision Date | 09/28/2012 |
Product Code |
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
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 |