Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K190656 |
Device Name |
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings |
Applicant |
Zimmer Inc. |
P.O. Box 708 |
Warsaw,
IN
46581 -0708
|
|
Applicant Contact |
Charles Neitzel |
Correspondent |
Zimmer Inc. |
P.O. Box 708 |
Warsaw,
IN
46581 -0708
|
|
Correspondent Contact |
Charles Neitzel |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/14/2019 |
Decision Date | 12/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|