Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K161192 |
Device Name |
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System |
Applicant |
ZIMMER GMBH |
SULZERALLEE 8 |
WINTERTHUR,
CH
8404
|
|
Applicant Contact |
ROBERTO TOMMASINI |
Correspondent |
ZIMMER GMBH |
SULZERALLEE 8 |
WINTERTHUR,
CH
8404
|
|
Correspondent Contact |
ANNE-KATHRIN BORN |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/27/2016 |
Decision Date | 07/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|