Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K121982 |
Device Name |
SOVEREIGN SPINAL SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
LAUREN KAMER |
Correspondent |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
LAUREN KAMER |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 07/06/2012 |
Decision Date | 07/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|