Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K171907 |
Device Name |
Vitality® Spinal Fixation System |
Applicant |
Zimmer Biomet Spine, Inc. |
10225 Westmoor Drive |
Westminster,
CO
80021
|
|
Applicant Contact |
Kelly Stratton |
Correspondent |
Zimmer Biomet Spine, Inc. |
10225 Westmoor Drive |
Westminster,
CO
80021
|
|
Correspondent Contact |
Kelly Stratton |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/26/2017 |
Decision Date | 07/14/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|