Device Classification Name |
Bone Cement, Antibiotic
|
510(k) Number |
K063857 |
Device Name |
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
TIFFANI ROGERS |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 CORPORATE DR |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
TIFFANI ROGERS |
Regulation Number | 888.3027
|
Classification Product Code |
|
Date Received | 12/28/2006 |
Decision Date | 02/26/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|