Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K210842 |
Device Name |
VerSys Cemented Revision/Calcar |
Applicant |
Zimmer, Inc. |
1800 W. Center Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Rhonda Myer |
Correspondent |
Zimmer, Inc. |
1800 W. Center Street |
Warsaw,
IN
46580
|
|
Correspondent Contact |
Katherine Choi |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 03/22/2021 |
Decision Date | 12/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|