Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K153152 |
Device Name |
Syzygy Stabilization System |
Applicant |
AMENDIA, INC. |
1755 WEST OAK PARKWAY |
MARIETTA,
GA
30062
|
|
Applicant Contact |
Kristen Allen |
Correspondent |
AMENDIA, INC. |
1755 WEST OAK PARKWAY |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
Kristen Allen |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/02/2015 |
Decision Date | 04/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|