Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
|
510(k) Number |
K051320 |
Device Name |
SATELLITE SPINAL SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
RICHARD W TREHARNE |
Correspondent |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
RICHARD W TREHARNE |
Classification Product Code |
|
Date Received | 05/20/2005 |
Decision Date | 09/09/2005 |
Decision |
SE - With Limitations
(SESU) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|