Device Classification Name |
shoulder arthroplasty implantation system
|
510(k) Number |
K200615 |
Device Name |
Signature ONE System |
Applicant |
Orthosoft Inc. (d/b/a Zimmer CAS) |
75 Queen Street Suite 3300 |
Montreal,
CA
H3C 2N6
|
|
Applicant Contact |
Sankalp Dere |
Correspondent |
Orthosoft Inc. (d/b/a Zimmer CAS) |
75 Queen Street Suite 3300 |
Montreal,
CA
H3C 2N6
|
|
Correspondent Contact |
Sankalp Dere |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/09/2020 |
Decision Date | 06/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|