Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K191648 |
Device Name |
Mariner MIS Pedicle Screw System; SeaSpine Navigation System |
Applicant |
SeaSpine Orthopedics Corporation |
5770 Armada Drive |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Alicia McArthur |
Correspondent |
SeaSpine Orthopedics Corporation |
5770 Armada Drive |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Aly Alvarez |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/20/2019 |
Decision Date | 07/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|