Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K120467 |
Device Name |
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM |
Applicant |
SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
BENJAMIN A KIMBALL |
Correspondent |
SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100 |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
BENJAMIN A KIMBALL |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/15/2012 |
Decision Date | 07/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|