Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K133216 |
Device Name |
CRESCENT SPINAL SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
ANKIT K SHAH |
Correspondent |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
ANKIT K SHAH |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 10/18/2013 |
Decision Date | 11/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|