Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K161120 |
Device Name |
SMR TT Metal Back Glenoid, Bone Graft instruments |
Applicant |
LIMACORPORATE S.P.A. |
VIA NAZIONALE 52 |
VILLANOVA DI SAN DANIELE,
IT
33038
|
|
Applicant Contact |
Emanuele Buttazzoni |
Correspondent |
PEOPLES & ASSOCIATES CONSULTING LLC |
5010 LODGE POLE LANE |
Fort Wayne,
IN
46814
|
|
Correspondent Contact |
Stephen Peoples |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/21/2016 |
Decision Date | 02/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|