Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal
|
510(k) Number |
K061243 |
FOIA Releasable 510(k) |
K061243
|
Device Name |
SMITH & NEPHEW MODULAR FEMORAL HEAD |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
GINO ROUSS |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
GINO ROUSS |
Regulation Number | 888.3360
|
Classification Product Code |
|
Date Received | 05/03/2006 |
Decision Date | 07/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|