Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K063741 |
Device Name |
EXPEDIUM SPINE SYSTEM |
Applicant |
DEPUY SPINE, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
CHRISTOPHER KLACZYK |
Correspondent |
DEPUY SPINE, INC. |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
CHRISTOPHER KLACZYK |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/18/2006 |
Decision Date | 01/17/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|