Device Classification Name |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K190595 |
Device Name |
Signature ONE System |
Applicant |
Orthosoft Inc. (d/b/a Zimmer CAS) |
75 Queen Street |
Suite 3300 |
Montreal,
CA
h3c 2n6
|
|
Applicant Contact |
Paul Hardy |
Correspondent |
Orthosoft Inc. (d/b/a Zimmer CAS) |
75 Queen Street |
Suite 3300 |
Montreal,
CA
h3c 2n6
|
|
Correspondent Contact |
Paul Hardy |
Regulation Number | 888.3650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/07/2019 |
Decision Date | 06/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|