Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K162160 |
Device Name |
Preference Elite Pedicle Screw System |
Applicant |
AMEDICA CORPORATION |
1885 W 2100 S |
Salt Lake City,
UT
84119
|
|
Applicant Contact |
Shanna Ryan |
Correspondent |
AMEDICA CORPORATION |
1885 West 2100 South |
Salt Lake City,
UT
84119
|
|
Correspondent Contact |
Shanna Ryan |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/02/2016 |
Decision Date | 11/18/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|