Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K213459 |
Device Name |
Glenoid Reconstruction System |
Applicant |
Medacta International S.A. |
Strada Regina |
Castel San Pietro,
CH
CH-6874
|
|
Applicant Contact |
Stefano Baj |
Correspondent |
Medacta USA |
3973 Delp Street |
Memphis,
TN
38118
|
|
Correspondent Contact |
Chris Lussier |
Regulation Number | 888.3660
|
Classification Product Code |
|
Date Received | 10/27/2021 |
Decision Date | 11/23/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|