Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K130728 |
Device Name |
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA |
Applicant |
SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
SAMEER MANSOUR |
Correspondent |
SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
SAMEER MANSOUR |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/18/2013 |
Decision Date | 10/10/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|