Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K182048 |
Device Name |
Avenir Complete Hip System |
Applicant |
Zimmer, Inc |
P.O. Box 708 |
Warsaw,
IN
46581 -0708
|
|
Applicant Contact |
Rebecca D Noftz |
Correspondent |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Correspondent Contact |
Neha Sreenath |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/31/2018 |
Decision Date | 12/07/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|