Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K141327 |
Device Name |
MINIMA S SYSTEM |
Applicant |
LIMACORPORATE S.P.A. |
5010 LODGE POLE LANE |
FORT WAYNE,
IN
46814
|
|
Applicant Contact |
STEPHEN PEOPLES |
Correspondent |
LIMACORPORATE S.P.A. |
5010 LODGE POLE LANE |
FORT WAYNE,
IN
46814
|
|
Correspondent Contact |
STEPHEN PEOPLES |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/21/2014 |
Decision Date | 08/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|