Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K122244 |
Device Name |
POLARCUP DUAL MOBILITY SYSTEM |
Applicant |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
JOHN CONNOR |
Correspondent |
SMITH & NEPHEW, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
JOHN CONNOR |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/27/2012 |
Decision Date | 08/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|