Device Classification Name |
Spinal Vertebral Body Replacement Device
|
510(k) Number |
K030249 |
Device Name |
SURGICAL TITANIUM MESH SYSTEM |
Applicant |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Applicant Contact |
KAREN F JURCZAK |
Correspondent |
DEPUY ACROMED |
325 PARAMOUNT DR. |
RAYNHAM,
MA
02767 -0350
|
|
Correspondent Contact |
KAREN F JURCZAK |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 01/24/2003 |
Decision Date | 02/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|