Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K220847 |
Device Name |
AETOS Shoulder System |
Applicant |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Applicant Contact |
Cassidy Lemkau |
Correspondent |
Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway |
Cordova,
TN
38016
|
|
Correspondent Contact |
Cassidy Lemkau |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/23/2022 |
Decision Date | 01/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|