Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K112091 |
Device Name |
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS |
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 | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2011 |
Decision Date | 11/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|