Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K173057 |
Device Name |
Zimmer Knee Joint Replacement Prostheses MR Labeling |
Applicant |
Zimmer, Inc. |
P.O. Box 708 |
Warsaw,
IN
46581 -0708
|
|
Applicant Contact |
Jason Heckaman |
Correspondent |
Zimmer, Inc. |
P.O. Box 708 |
Warsaw,
IN
46581 -0708
|
|
Correspondent Contact |
Jason Heckaman |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/28/2017 |
Decision Date | 03/29/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|