Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K112898 |
Device Name |
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS |
Applicant |
LIMACORPORATE S.P.A. |
P.O. BOX 696 |
WINONA LAKE,
IN
46590 -696
|
|
Applicant Contact |
CHERYL HASTINGS |
Correspondent |
LIMACORPORATE S.P.A. |
P.O. BOX 696 |
WINONA LAKE,
IN
46590 -696
|
|
Correspondent Contact |
CHERYL HASTINGS |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/03/2011 |
Decision Date | 12/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|