Device Classification Name |
ankle arthroplasty implantation system
|
510(k) Number |
K231585 |
Device Name |
Vantage PSI System |
Applicant |
3D Systems, Inc. |
5381 South Alkire Circle |
Littleton,
CO
80127
|
|
Applicant Contact |
Ashley Dawson |
Correspondent |
3D Systems, Inc. |
5381 South Alkire Circle |
Littleton,
CO
80127
|
|
Correspondent Contact |
Ashley Dawson |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 05/31/2023 |
Decision Date | 06/30/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|