Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K042953 |
Device Name |
MODIFICATION TO PROTEX STABILIZATION SYSTEM |
Applicant |
GLOBUS MEDICAL, INC. |
303 SCHELL LANE |
PHOENIXVILLE,
PA
19460
|
|
Applicant Contact |
KELLY J BAKER |
Correspondent |
GLOBUS MEDICAL, INC. |
303 SCHELL LANE |
PHOENIXVILLE,
PA
19460
|
|
Correspondent Contact |
KELLY J BAKER |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/26/2004 |
Decision Date | 11/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|