Device Classification Name |
ankle arthroplasty implantation system
|
510(k) Number |
K193432 |
Device Name |
Vantage PSI System |
Applicant |
3D Systems |
5381 South Alkire Circle |
Littleton,
CO
80127
|
|
Applicant Contact |
Kim Torluemke |
Correspondent |
3D Systems |
5381 South Alkire Circle |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kim Torluemke |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 12/10/2019 |
Decision Date | 11/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|