| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
| |
| Trade Name | SECURE-C ARTIFICIAL CERVICAL DISC |
|---|
| Classification Name | prosthesis, intervertebral disc |
|---|
| Applicant | GLOBUS MEDICAL INC. |
|---|
| PMA Number | P100003 |
|---|
| Date Received | 01/29/2010 |
|---|
| Decision Date | 09/28/2012 |
|---|
| Product Code | |
| Docket Number | 12M-1039 |
|---|
| Notice Date | 10/02/2012 |
|---|
| Advisory Committee |
Orthopedic |
|---|
| Clinical Trials |
NCT00882661
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the secure-c artificial cervical disc. This device is indicated in skeletally mature patients for reconstruction of the 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-level abnormality 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
|
| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 |
|
|
