Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K122229 |
Device Name |
VICEROY SPINAL SYSTEM |
Applicant |
TORREY SPINE |
4628 NORTHPARK DRIVE |
COLORADO SPRINGS,
CO
80918
|
|
Applicant Contact |
MEREDITH MAY |
Correspondent |
TORREY SPINE |
4628 NORTHPARK DRIVE |
COLORADO SPRINGS,
CO
80918
|
|
Correspondent Contact |
MEREDITH MAY |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/26/2012 |
Decision Date | 11/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|