Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K191781 |
Device Name |
Wagner SL Revision Stem Lateral and 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 | 07/02/2019 |
Decision Date | 08/06/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|