Device Classification Name |
Posterior Metal/Polymer Spinal System, Fusion
|
510(k) Number |
K073439 |
Device Name |
TRANSITION STABILIZATION SYSTEM |
Applicant |
GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. |
AUDUBON,
PA
19403
|
|
Applicant Contact |
KELLY J BAKER |
Correspondent |
GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. |
AUDUBON,
PA
19403
|
|
Correspondent Contact |
KELLY J BAKER |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 12/07/2007 |
Decision Date | 02/20/2009 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|