Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K142752 |
Device Name |
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System |
Applicant |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Applicant Contact |
DONNA M. SEMLAK |
Correspondent |
ZIMMER SPINE, INC. |
7375 BUSH LAKE RD. |
MINNEAPOLIS,
MN
55439
|
|
Correspondent Contact |
DONNA M. SEMLAK |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/24/2014 |
Decision Date | 06/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|