Device Classification Name |
bone cement
|
510(k) Number |
K033563 |
Device Name |
SMARTSET GHV GENTAMICIN BONE CEMENT |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
TIFFANI D ROGERS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
TIFFANI D ROGERS |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/12/2003 |
Decision Date | 02/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|