Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K161405 |
Device Name |
Valeo II Interbody Fusion Device System |
Applicant |
AMEDICA CORP. |
1885 WEST 2100 SOUTH |
Salt Lake City,
UT
84119
|
|
Applicant Contact |
William D. Jordan |
Correspondent |
AMEDICA CORP. |
1885 WEST 2100 SOUTH |
Salt Lake City,
UT
84119
|
|
Correspondent Contact |
William D. Jordan |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/20/2016 |
Decision Date | 08/19/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|