Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
510(k) Number |
K081124 |
Device Name |
MDF REVISION HIP SYSTEM |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
RISHI SINHA |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
RISHI SINHA |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 04/21/2008 |
Decision Date | 07/31/2008 |
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
|
|
|