Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K191746 |
Device Name |
SMR TT Augmented Glenoid System |
Applicant |
Limacorporate S.p.A |
via Nazionale 52 |
Villanova di San Daniele del Friuli,
IT
33038
|
|
Applicant Contact |
Michela Zanotto |
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 | 07/01/2019 |
Decision Date | 11/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|