Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
|
510(k) Number |
K161233 |
Device Name |
OXINIUM DH Fermoral Heads |
Applicant |
SMITH & NEPHEW, INC. |
7135 GOODLETT FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Applicant Contact |
MIKE SCOTT |
Correspondent |
SMITH & NEPHEW, INC. |
7135 GOODLETT FARMS PARKWAY |
CORDOVA,
TN
38016
|
|
Correspondent Contact |
MIKE SCOTT |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2016 |
Decision Date | 12/14/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|