Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K181171 |
Device Name |
Zimmer Biomet Ceramic Heads |
Applicant |
Zimmer, Inc |
P.O Box 708 |
Warsaw,
IN
46581 -0708
|
|
Applicant Contact |
Carol Vierling |
Correspondent |
Zimmer, Inc |
P.O Box 708 |
Warsaw,
IN
46581 -0708
|
|
Correspondent Contact |
Carol Vierling |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2018 |
Decision Date | 04/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|