Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K062447 |
Device Name |
TRAVERSE OCT SPINAL FIXATION SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
ED CHIN |
Correspondent |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
ED CHIN |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/22/2006 |
Decision Date | 10/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|