Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K122226 |
Device Name |
REVERE STABILIZATION SYSTEM |
Applicant |
GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. |
AUDUBON,
PA
19403
|
|
Applicant Contact |
MERIAM YOUSSEF |
Correspondent |
GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. |
AUDUBON,
PA
19403
|
|
Correspondent Contact |
MERIAM YOUSSEF |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/26/2012 |
Decision Date | 10/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|