Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K131980 |
Device Name |
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM |
Applicant |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Applicant Contact |
JONATHAN GILBERT |
Correspondent |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Correspondent Contact |
JONATHAN GILBERT |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/28/2013 |
Decision Date | 09/04/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|