Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K133291 |
Device Name |
ST360 DEGREES SPINAL FIXATION SYSTEM |
Applicant |
ZIMMER SPINE, INC |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
MICHELLE LENZ |
Correspondent |
ZIMMER SPINE, INC |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
MICHELLE LENZ |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/25/2013 |
Decision Date | 12/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|