Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K143739 |
Device Name |
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA |
Applicant |
SMITH & NEPHEW, INC. |
7135 GOODLETT FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Applicant Contact |
JEFF SPRAGUE |
Correspondent |
SMITH & NEPHEW, INC. |
7135 GOODLETT FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Correspondent Contact |
JEFF SPRAGUE |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/30/2014 |
Decision Date | 04/20/2015 |
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
|
|
|