Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K230321 |
Device Name |
Persona™ Personalized Knee System |
Applicant |
Zimmer, Inc. |
1800 W. Center Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Gregory Foster |
Correspondent |
Zimmer, Inc. |
1800 W. Center Street |
Warsaw,
IN
46580
|
|
Correspondent Contact |
Gregory Foster |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/06/2023 |
Decision Date | 03/08/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|