Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K142347 |
Device Name |
Amedica Valeo II Interbody Fusion Device |
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 | 08/22/2014 |
Decision Date | 11/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|