Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K110598 |
Device Name |
SMR REVERSE SHOULDER SYSTEM |
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 | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/02/2011 |
Decision Date | 08/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|