Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
510(k) Number |
K222566 |
Device Name |
Zimmer Persona Personalized Knee System |
Applicant |
Zimmer, Inc. |
1800 W Center Street |
Warsaw,
IN
46580
|
|
Applicant Contact |
Lauren Ricker |
Correspondent |
Zimmer, Inc. |
1800 W Center Street |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Lauren Ricker |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/24/2022 |
Decision Date | 10/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|