| 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 | BRYAN CERVICAL DISC PROSTHESIS |
|---|
| Classification Name | prosthesis, intervertebral disc |
|---|
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. |
|---|
| PMA Number | P060023 |
|---|
| Date Received | 06/29/2006 |
|---|
| Decision Date | 05/12/2009 |
|---|
| Product Code | |
| Docket Number | 09M-0243 |
|---|
| Notice Date | 05/27/2009 |
|---|
| Advisory Committee |
Orthopedic |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the bryan cervical disc. The device is indicated in skeletally mature patients for reconstruction of the disc from c3-c7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The bryan device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy is defined as any combination of the following: disc herniation with radiculopathy. Spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy resulting in impaired function and at least one clinical neurological sign associated with the cervical level to be treated, and necessitating surgery as demonstrated using computed tomography (ct), myelography and ct, and/or magnetic resonance imaging (mr1). Patients receiving the bryan cervical disc should have failed at least six weeks of non-operative treatment prior to implantation of the bryan cervical disc. |
| Approval Order |
Approval Order
|
| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S003 S004 |
|
|
